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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-02317 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I 659920 | Other Identifier | Roswell Park Cancer Institute | |
| P30CA016056 | U.S. NIH Grant/Contract | View source |
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Low accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| AIM ImmunoTech Inc. | INDUSTRY |
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This phase I/IIa trial studies the best dose and side effects of rintatolimod and interferon (IFN) alpha-2b in treating cancer patients with COVID-19 infection. Interferon alpha is a protein important for defense against viruses. It activates immune responses that help to clear viral infection. Rintatolimod is double stranded ribonucleic acid (RNA) designed to mimic viral infection by stimulating immune pathways that are normally activated during viral infection. Giving rintatolimod and interferon alpha-2b may activate the immune system to limit the replication and spread of the virus.
PRIMARY OBJECTIVES:
I. To determine the safety of the combination of intravenous (i.v.) rintatolimod administered with or without i.v. IFN alpha (recombinant interferon alfa-2b [Intron A]) in patients with cancer with coronavirus disease 2019 (COVID-19).
II. Determine the kinetics of viral load in nasopharyngeal swabs in the course of treatment and Days 7 and 14.
SECONDARY OBJECTIVES:
I. To assess the efficacy of the treatment combination in patients with cancer with COVID-19.
II. Determine the kinetics of viral load in the peripheral blood in the course of treatment and Days 7 and 14.
III. Determine the kinetics of changes of the immune subsets and circulating inflammatory mediators (including C-reactive protein [CRP], cytokines, chemokines, interferons) in peripheral blood in the course of treatment and Days 7 and 14.
IV. Determine the induction of known mediators of antiviral immunity that include (myxovirus resistance gene, MxA; protein Kinase R (PKR); oligoadenylate synthetase-2 (OAS2); RNAse-L, IFN-stimulated gene-15 (ISG15); IFN-induced proteins with tetratricopeptide repeats (IFIT1) and IFN-inducible transmembrane protein 3 (IFITM3), TLR3, RIG-I, MDA5, IRF3, IRF7, in nasopharyngeal swabs material and blood cells of patients on all tiers of treatment.
OUTLINE: This is a phase I, dose-escalation study of recombinant interferon alfa-2b followed by a phase II study.
LEAD-IN PHASE: Patients receive rintatolimod IV over 2.5-3 hours on day 1 and day 3 (or 4).
ARM I: Patients receive rintatolimod IV over 2.5-3 hours and recombinant interferon alfa-2b IV over 20 minutes on day 1 and on day 3 or 4 in the absence of disease progression or unacceptable toxicity.
EXPANSION COHORT:
ARM III: Patients receive rintatolimod IV over 2.5-3 hours along with standard of care.
Patients are followed up at days 7, 14 and 30 after initiation of the study regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rintatolimod, recombinant interferon alfa-2b 0 MU/M^2 | Experimental | Dose level 1:Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 0 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. |
|
| Rintatolimod, recombinant interferon alfa-2b 5 MU/M^2 | Experimental | Dose level 2 :Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 5 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. |
|
| Rrintatolimod plus Standard of Care) | Experimental | Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care. |
|
| Rintatolimod, recombinant interferon alfa-2b 10 MU/M^2 | Experimental | Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. |
|
| Rintatolimod, recombinant interferon alfa-2b 20 MU/M^2 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Interferon Alfa-2b | Biological | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | This refers to the frequency of grade 3 or 4 AEs considered to be probably or definitely related to the treatment regimen. Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE version [v] 5.0). | Up to 30 days post treatment initiation, On average, the timeframe is 25 days |
| Kinetics of Viral Load | Will be assessed as cycle threshold values in nasopharyngeal swabs based on quantitative polymerase chain reaction (PCR) in the course of treatment and days 1, 3/4, 7, and 11. | Treatment and days 1, 3/4, 7 and 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Selected Clinical Efficacy Complications | Will be assessed by the frequency of these complications: (i) progression of infection requiring hospitalization; (ii) respiratory failure requiring mechanical ventilation (primary efficacy endpoint); and (iii) death within 30 days. If present, acute respiratory distress syndrome will be graded by Berlin criteria. | Up to 30 days post treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Known Mediators of Antiviral Immunity | Will assess the induction of known mediators of antiviral immunity that include (myxovirus resistance gene, MxA; protein Kinase R; oligoadenylate synthetase-2; RNAse-L, IFN-stimulated gene-15 (ISG15); IFN-induced proteins with tetratricopeptide repeats, and IFN-inducible transmembrane protein 3, TLR3, RIG-I, MDA5, IRF3, IRF7, in nasopharyngeal swabs material and blood cells of patients on all tiers of treatment. Will also assess the expression of ACE2 (receptor for severe acute respiratory syndrome coronavirus 2 [SARS-Cov-2] entry) and potentially other genes involved in SARS-CoV-2 infection will be tested in nasopharyngeal samples. |
Inclusion Criteria:
INCLUSION CRITERIA (MAIN COHORT):
Patients with cancer, with the exception of patients with active acute leukemia and allogeneic hematopoietic stem cell transplant recipients. Patients may be on active therapy or received therapy (e.g., chemotherapy, radiation or surgery) within 7 years. Patients with active cancer who have not yet been treated (e.g. newly diagnosed cancer or early stage myelodysplastic syndrome [MDS] or chronic lymphocytic leukemia [CLL]) are eligible. Basal cell cancer and carcinoma in situ treated with local excision alone do not qualify for inclusion
Presence of symptomatic infection, defined by fever (temperature [T] >= 38 degrees Celsius [C]) OR respiratory symptoms (cough, nasal congestion, or shortness of breath) OR lung infilitrates on chest X-ray or CT imaging. Diagnosis of COVID-19 is based on polymerase chain reaction (PCR) testing of respiratory samples.
Age equal to >= 18 years or older (children are excluded because COVID-19 typically has a milder course in children, and lack of safety data of this regimen in children)
Platelet >= 75,000/uL
Hemoglobin >= 9 g/dL
Hematocrit >= 27%
Absolute neutrophil count (ANC) >= 1000/uL
Creatinine clearance >= 50 mL/min (Cockcroft-Gault Equation-note: plasma creatine instead of serum is used at Roswell Park)
Total bilirubin =< 2 X institutional upper limit of normal (ULN)
Aspartate transaminase (AST) (plasma) and alanine transferase (ALT) (plasma) =< 2 X institutional ULN
Plasma amylase and lipase =< 2 X institutional ULN
In the absence of COVID-19, a life expectancy of 6 months is expected
Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
NOTE: For blood chemistry labs, Roswell Park clinical blood chemistries are performed on plasma unless otherwise indicated
EXPANSION COHORT: Patients with cancer or allogeneic stem cell transplant recipients with and without a cancer diagnosis
Presence of symptomatic infection, defined by fever (T >= 38.0 degrees C ) OR respiratory symptoms (cough, nasal congestion, or shortness of breath) OR lung infiltrates by chest X-ray or CT imaging. Diagnosis of COVID-19 is based on PCR testing of respiratory samples. Severe infection is excluded
Age equal to >= 18 years or older (children are excluded because COVID-19 typically has a milder course in children, and lack of safety data of this regimen in children). In the absence of COVID-19, a life expectancy of 6 months is expected
Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure. There may be specific instances when the patient can't provide informed consent, e.g. they require mechanical ventilation and are sedated, in which case a health care proxy will be able to provide informed consent. Patients with temporary cognitive impairment will be consented once their capacity has returned. Patients with chronic cognitive impairment, e.g. dementia, that precludes informed consent will not be enrolled.
Exclusion Criteria:
EXCLUSION CRITERIA (MAIN COHORT):
Patients with severe COVID-19 infection defined by pulmonary infiltrates on chest x-ray or computed tomography (CT) imaging plus one of the following: room air oxygen saturation (SaO2) =< 92%, room air partial pressure of oxygen (PaO2) < 70 mm Hg, or partial pressure of oxygen in arterial blood (PaO2)-PaO2 (alveolar gas) >= 35 mm Hg
Contraindication to recombinant (r)-INFalpha based on prior hypersensitivity, autoimmune hepatitis, decompensated liver disease
Patients who have active acute myeloid leukemia or acute lymphoid leukemia or are allogeneic hematopoietic stem transplant recipients. Acute leukemia in remission and chronic leukemias are not exclusion criteria
Cardiac events:
Unwilling or unable to follow protocol requirements
Patients with known serious mood disorders
Any additional condition, such as pre-existing inflammatory lung disease, which in the investigator's opinion deems the participant an unsuitable candidate to receive the study drugs
Concurrent infections, e.g. bacterial pneumonia or sepsis, that would make it difficult to evaluate clinical response to therapy or study drug toxicities
Therapies known to cause cytokine release syndrome (CRS), e.g. engineered T cells, within 30 days
Patients at high risk for tumor lysis syndrome
Concurrent active pneumonitis predating COVID-19, such as from checkpoint inhibitor therapy, chemotherapy-associated toxicity, or radiation pneumonitis
Autoimmune disease that requires systemic immunosuppression
Protocol-defined baseline abnormalities in cell counts, renal, or hepatic function
Any additional condition which in the investigator's opinion deems the participant an unsuitable candidate to receive the study drugs
EXCLUSION CRITERIA: EXPANSION COHORT:
Patients with respiratory failure requiring mechanical ventilation with FIO2 of > 60%.
Allogeneic hematopoietic stem cell transplant recipients with active pulmonary graft versus host disease (GvHD) (any grade)
Cardiac events:
Unwilling or unable to follow protocol requirements
Any additional condition which in the investigator's opinion deems the participant an unsuitable candidate to receive the study drugs
Cognitively impaired adults/adults with impaired decision-making capacity
Individuals who are not yet adults (infants, children, teenagers)
Pregnant women
Prisoners
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| Name | Affiliation | Role |
|---|---|---|
| Igor Puzanov | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 0 MU/M^2 | Dose level 1:Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 0 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 6, 2025 |
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| Experimental |
Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. |
|
|
| Rintatolimod | Drug | Given IV |
|
|
| Kinetics of Viral Load | Will be assessed as cycle threshold values in the peripheral blood and nasopharyngeal swab based on quantitative PCR in the course of treatment and days 1, 3, 7, and 14. Data entered are values that were measured, no "placeholders" were entered, zero is a valid measurement. | Days 1, 3, 7, 14 post treatment initiation |
| Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (COX2) | Gene expresssion measured by qPCR | Days 1, 4 , 7, 14 and 30 post treatment initiation |
| Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CCL5) | Gene expression measured by QPCR | Days 1, 4, 7, 14 and 30 post treatment |
| Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CXCL10) | Gene expression measured by qPCR | Days 1, 4, 7, 14, and 30 post treatment |
| Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CCL22) | Gene expression measured by qPCR | Days 1, 4, 7, 14 and 30 post treatment |
| Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CXCL12) | Gene expression measured by qPCR | Days 1, 4, 7, and 30 post treatment |
| Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (IL-10) | gene expression measured by qPCR | Days 1, 4, 7, 14 and 30 post treatment |
| Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (IDO1) | Gene expression measured by qPCR | Days 1, 4, 7, 14 and 30 post treatment |
| Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (IFNB1) | Gene expression measured by qPCR | Days 1, 4, 7, 14 and 30 post treatment |
| Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (IFNa) | Gene expression measured by qPCR | Days 1, 4, 7, 14 and 30 post treatment |
| Known Mediators of Antiviral Immunity (RIG-1) | Induction of known mediator RIG-1 of antiviral immunity measured by qPCR | Days 1, 4, 7, 14 and 30 post treatment |
| Known Mediators of Antiviral Immunity (TLR-3) | Induction of known mediator TLR-3 of antiviral immunity measured by qPCR | Days 1, 4, 7, 14 and 30 post treatment |
| Known Mediators of Antiviral Immunity (ISG-15) | Induction of known mediator ISG-15 of antiviral immunity measured by qPCR | Days 1, 4, 7, 14 and 30 post treatment |
| Known Mediators of Antiviral Immunity (RNAseL) | Induction of known mediator RNAseL of antiviral immunity measured by qPCR | Days 1, 4, 7, 14 and 30 post treatment |
| Known Mediators of Antiviral Immunity (OAS2) | Induction of known mediator OAS2 of antiviral immunity measured by qPCR | Days 1, 4, 7, 14 and 30 post treatment |
| Known Mediators of Antiviral Immunity (ACE2) | Induction of known mediator ACE2 of antiviral immunity measured by qPCR | Days 1, and 14 post treatment |
| Known Mediators of Antiviral Immunity (Mx1) | Induction of known mediator Mx1 of antiviral immunity measured by qPCR | Days 1, 4, 7, 14 and 30 post treatment |
| Known Mediators of Antiviral Immunity (IFIT1) | Induction of known mediator IFIT1 of antiviral immunity measured by qPCR | Days 1, 4, 7, 14 and 30 post treatment |
| Known Mediators of Antiviral Immunity (IFITM3) | Induction of known mediator IFITM3 of antiviral immunity measured by qPCR | Days 1, 4, 7, 14 and 30 post treatment |
| Known Mediators of Antiviral Immunity (IRF3) | Induction of known mediator IRF3 of antiviral immunity measured by qPCR | Days 1, 4, 7, 14 and 30 post treatment |
| Known Mediators of Antiviral Immunity (IRF7) | Induction of known mediator IRF7 of antiviral immunity measured by qPCR | Days 1, 4, 7, 14 and 30 post treatment |
| Up to 30 days post treatment initiation |
| FG001 | 2. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 5 MU/M^2 | Dose level 2 :Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 5 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| FG002 | 3. Experimental: Rrintatolimod Plus Standard of Care) | Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care. Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| FG003 | 4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2 | Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| FG004 | 5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2 | Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| COMPLETED |
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| NOT COMPLETED |
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All treated and eligible patients
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| ID | Title | Description |
|---|---|---|
| BG000 | 1. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 0 MU/M^2 | Dose level 1:Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 0 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| BG001 | 2. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 5 MU/M^2 | Dose level 2 :Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 5 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| BG002 | 3. Experimental: Rrintatolimod Plus Standard of Care) | Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care. Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| BG003 | 4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2 | Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| BG004 | 5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2 | Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) | This refers to the frequency of grade 3 or 4 AEs considered to be probably or definitely related to the treatment regimen. Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE version [v] 5.0). | All treated and eligible patients | Posted | Count of Participants | Participants | Up to 30 days post treatment initiation, On average, the timeframe is 25 days |
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| Primary | Kinetics of Viral Load | Will be assessed as cycle threshold values in nasopharyngeal swabs based on quantitative polymerase chain reaction (PCR) in the course of treatment and days 1, 3/4, 7, and 11. | All treated and eligible patients | Posted | Mean | Standard Deviation | Viral Copy Number / mL | Treatment and days 1, 3/4, 7 and 11 |
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| Secondary | Number of Participants With Selected Clinical Efficacy Complications | Will be assessed by the frequency of these complications: (i) progression of infection requiring hospitalization; (ii) respiratory failure requiring mechanical ventilation (primary efficacy endpoint); and (iii) death within 30 days. If present, acute respiratory distress syndrome will be graded by Berlin criteria. | All treated and evaluable participants | Posted | Count of Participants | Participants | Up to 30 days post treatment initiation |
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| Secondary | Kinetics of Viral Load | Will be assessed as cycle threshold values in the peripheral blood and nasopharyngeal swab based on quantitative PCR in the course of treatment and days 1, 3, 7, and 14. Data entered are values that were measured, no "placeholders" were entered, zero is a valid measurement. | All treated and eligible patients | Posted | Mean | Standard Deviation | Relative mRNA abundance | Days 1, 3, 7, 14 post treatment initiation |
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| Secondary | Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (COX2) | Gene expresssion measured by qPCR | All treated and eligible patients | Posted | Mean | Standard Deviation | Relative mRNA abundance | Days 1, 4 , 7, 14 and 30 post treatment initiation |
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| Secondary | Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CCL5) | Gene expression measured by QPCR | All treated and eligible patients | Posted | Mean | Standard Deviation | Relative mRNA abundance | Days 1, 4, 7, 14 and 30 post treatment |
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| Secondary | Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CXCL10) | Gene expression measured by qPCR | All treated and eligible patients | Posted | Mean | Standard Deviation | Relative mRNA abundance | Days 1, 4, 7, 14, and 30 post treatment |
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| Secondary | Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CCL22) | Gene expression measured by qPCR | All treated and eligible patients | Posted | Mean | Standard Deviation | Relative mRNA abundance | Days 1, 4, 7, 14 and 30 post treatment |
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| Secondary | Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (CXCL12) | Gene expression measured by qPCR | All treated and eligible patients, participants with data collected at each time point were analyzed. | Posted | Mean | Standard Deviation | Relative mRNA abundance | Days 1, 4, 7, and 30 post treatment |
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| Secondary | Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (IL-10) | gene expression measured by qPCR | All treated and eligible patients | Posted | Mean | Standard Deviation | Relative mRNA abundance | Days 1, 4, 7, 14 and 30 post treatment |
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| Secondary | Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (IDO1) | Gene expression measured by qPCR | All treated and eligible patients | Posted | Median | Standard Deviation | Relative mRNA abundance | Days 1, 4, 7, 14 and 30 post treatment |
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| Secondary | Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (IFNB1) | Gene expression measured by qPCR | All treated and eligible patients | Posted | Mean | Standard Deviation | Relative mRNA abundance | Days 1, 4, 7, 14 and 30 post treatment |
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| Secondary | Kinetics of Changes of the Immune Subsets and Circulating Inflammatory Mediators in Peripheral Blood (IFNa) | Gene expression measured by qPCR | All treated and eligible patients | Posted | Mean | Standard Deviation | Relative mRNA abundance | Days 1, 4, 7, 14 and 30 post treatment |
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| Secondary | Known Mediators of Antiviral Immunity (RIG-1) | Induction of known mediator RIG-1 of antiviral immunity measured by qPCR | All treated and eligible patients | Posted | Mean | Standard Deviation | Relative mRNA abundance | Days 1, 4, 7, 14 and 30 post treatment |
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| Secondary | Known Mediators of Antiviral Immunity (TLR-3) | Induction of known mediator TLR-3 of antiviral immunity measured by qPCR | All treated and eligible patients | Posted | Mean | Standard Deviation | Relative mRNA abundance | Days 1, 4, 7, 14 and 30 post treatment |
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| Secondary | Known Mediators of Antiviral Immunity (ISG-15) | Induction of known mediator ISG-15 of antiviral immunity measured by qPCR | All treated and eligible patients | Posted | Mean | Standard Deviation | Relative mRNA abundance | Days 1, 4, 7, 14 and 30 post treatment |
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| Secondary | Known Mediators of Antiviral Immunity (RNAseL) | Induction of known mediator RNAseL of antiviral immunity measured by qPCR | All treated and eligible patients | Posted | Mean | Standard Deviation | Relative mRNA abundance | Days 1, 4, 7, 14 and 30 post treatment |
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| Secondary | Known Mediators of Antiviral Immunity (OAS2) | Induction of known mediator OAS2 of antiviral immunity measured by qPCR | All treated and eligible patients | Posted | Mean | Standard Deviation | Relative mRNA abundance | Days 1, 4, 7, 14 and 30 post treatment |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Known Mediators of Antiviral Immunity (ACE2) | Induction of known mediator ACE2 of antiviral immunity measured by qPCR | All treated and eligible patients | Posted | Mean | Standard Deviation | Relative mRNA abundance | Days 1, and 14 post treatment |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Known Mediators of Antiviral Immunity (Mx1) | Induction of known mediator Mx1 of antiviral immunity measured by qPCR | All treated and eligible patients | Posted | Mean | Standard Deviation | Relative mRNA abundance | Days 1, 4, 7, 14 and 30 post treatment |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Known Mediators of Antiviral Immunity (IFIT1) | Induction of known mediator IFIT1 of antiviral immunity measured by qPCR | All treated and eligible patients | Posted | Mean | Standard Deviation | Relative mRNA abundance | Days 1, 4, 7, 14 and 30 post treatment |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Known Mediators of Antiviral Immunity (IFITM3) | Induction of known mediator IFITM3 of antiviral immunity measured by qPCR | All treated and eligible patients | Posted | Mean | Standard Deviation | Relative mRNA abundance | Days 1, 4, 7, 14 and 30 post treatment |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Known Mediators of Antiviral Immunity (IRF3) | Induction of known mediator IRF3 of antiviral immunity measured by qPCR | All treated and eligible patients | Posted | Mean | Standard Deviation | Relative mRNA abundance | Days 1, 4, 7, 14 and 30 post treatment |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Known Mediators of Antiviral Immunity (IRF7) | Induction of known mediator IRF7 of antiviral immunity measured by qPCR | All treated and eligible patients | Posted | Mean | Standard Deviation | Relative mRNA abundance | Days 1, 4, 7, 14 and 30 post treatment |
| |||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Known Mediators of Antiviral Immunity | Will assess the induction of known mediators of antiviral immunity that include (myxovirus resistance gene, MxA; protein Kinase R; oligoadenylate synthetase-2; RNAse-L, IFN-stimulated gene-15 (ISG15); IFN-induced proteins with tetratricopeptide repeats, and IFN-inducible transmembrane protein 3, TLR3, RIG-I, MDA5, IRF3, IRF7, in nasopharyngeal swabs material and blood cells of patients on all tiers of treatment. Will also assess the expression of ACE2 (receptor for severe acute respiratory syndrome coronavirus 2 [SARS-Cov-2] entry) and potentially other genes involved in SARS-CoV-2 infection will be tested in nasopharyngeal samples. | No patients were evaluable. | Posted | Up to 30 days post treatment initiation |
|
Routine AEs occurring between the start date of intervention until 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible, will be reported. up to 30 days post treatment initiation for an average timeframe of 25 days.
Due to the study's early termination, as a result of low accrual, target accrual was not reached, and additional treatment arms were not accrued.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 0 MU/M^2 | Dose level 1:Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 0 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD | 3 | 4 | 2 | 4 | 3 | 4 |
| EG001 | 2. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 5 MU/M^2 | "Dose level 2 :Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 5 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD" | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | 3. Experimental: Rrintatolimod Plus Standard of Care) | "Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care. Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD" | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | 4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2 | "Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD" | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | 5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2 | "Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD" | 0 | 0 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infections and infestations - Other, specify | Infections and infestations | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Edema limbs | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Flu like symptoms | General disorders | Systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Systematic Assessment |
| ||
| Platelet count decreased | Investigations | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Thromboembolic event | Vascular disorders | Systematic Assessment |
|
Due to the study's early termination, as a result of low accrual, target accrual was not reached and no statistical inference of the primary and secondary aims were carried forth.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Administrator, Compliance - Clinical Research Services | Roswell Park Cancer Institute | 716-845-2300 | igor.puzanov@roswellpark.org |
| Mar 28, 2025 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007438 | Introns |
| D000077190 | Interferon alpha-2 |
| C047490 | poly(I).poly(c12,U) |
| ID | Term |
|---|---|
| D021901 | DNA, Intergenic |
| D040481 | Genome Components |
| D016678 | Genome |
| D040342 | Genetic Structures |
| D055614 | Genetic Phenomena |
| D040461 | Gene Components |
| D005796 | Genes |
| D016898 | Interferon-alpha |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | 3. Experimental: Rrintatolimod Plus Standard of Care) | Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care. Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG003 | 4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2 | Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG004 | 5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2 | Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
|
|
| OG002 | 3. Experimental: Rrintatolimod Plus Standard of Care) | Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care. Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG003 | 4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2 | Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG004 | 5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2 | Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
|
|
| OG002 | 3. Experimental: Rrintatolimod Plus Standard of Care) | Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care. Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG003 | 4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2 | Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG004 | 5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2 | Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
|
|
| OG002 | 3. Experimental: Rrintatolimod Plus Standard of Care) | Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care. Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG003 | 4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2 | Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG004 | 5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2 | Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
|
|
| OG002 | 3. Experimental: Rrintatolimod Plus Standard of Care) | Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care. Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG003 | 4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2 | Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG004 | 5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2 | Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
|
|
| OG002 | 3. Experimental: Rrintatolimod Plus Standard of Care) | Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care. Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG003 | 4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2 | Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG004 | 5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2 | Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
|
|
| OG002 | 3. Experimental: Rrintatolimod Plus Standard of Care) | Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care. Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG003 | 4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2 | Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG004 | 5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2 | Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
|
|
| OG002 | 3. Experimental: Rrintatolimod Plus Standard of Care) | Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care. Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG003 | 4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2 | Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG004 | 5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2 | Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
|
|
| OG002 | 3. Experimental: Rrintatolimod Plus Standard of Care) | Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care. Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG003 | 4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2 | Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG004 | 5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2 | Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
|
|
| OG002 | 3. Experimental: Rrintatolimod Plus Standard of Care) | Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care. Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG003 | 4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2 | Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG004 | 5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2 | Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
|
|
| OG002 | 3. Experimental: Rrintatolimod Plus Standard of Care) | Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care. Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG003 | 4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2 | Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG004 | 5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2 | Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
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| OG002 | 3. Experimental: Rrintatolimod Plus Standard of Care) | Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care. Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG003 | 4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2 | Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG004 | 5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2 | Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
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| OG002 | 3. Experimental: Rrintatolimod Plus Standard of Care) | Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care. Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG003 | 4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2 | Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG004 | 5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2 | Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
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| OG002 | 3. Experimental: Rrintatolimod Plus Standard of Care) | Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care. Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG003 | 4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2 | Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG004 | 5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2 | Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
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| OG002 | 3. Experimental: Rrintatolimod Plus Standard of Care) | Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care. Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG003 | 4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2 | Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG004 | 5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2 | Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
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| OG002 | 3. Experimental: Rrintatolimod Plus Standard of Care) | Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care. Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG003 | 4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2 | Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG004 | 5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2 | Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
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| OG002 | 3. Experimental: Rrintatolimod Plus Standard of Care) | Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care. Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG003 | 4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2 | Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG004 | 5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2 | Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
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| OG002 | 3. Experimental: Rrintatolimod Plus Standard of Care) | Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care. Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG003 | 4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2 | Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG004 | 5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2 | Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
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| OG002 | 3. Experimental: Rrintatolimod Plus Standard of Care) | Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care. Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG003 | 4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2 | Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG004 | 5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2 | Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
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| OG002 | 3. Experimental: Rrintatolimod Plus Standard of Care) | Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care. Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG003 | 4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2 | Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG004 | 5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2 | Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
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| OG002 | 3. Experimental: Rrintatolimod Plus Standard of Care) | Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care. Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG003 | 4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2 | Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG004 | 5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2 | Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
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| OG002 | 3. Experimental: Rrintatolimod Plus Standard of Care) | Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care. Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG003 | 4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2 | Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG004 | 5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2 | Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
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| OG002 | 3. Experimental: Rrintatolimod Plus Standard of Care) | Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care. Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG003 | 4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2 | Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG004 | 5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2 | Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
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Dose level 2 :Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 5 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity.
Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV
Other Names:
Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV
Other Names:
Ampligen Atvogen RINTATOLIMOD
| OG002 | 3. Experimental: Rrintatolimod Plus Standard of Care) | Patients receive rintatolimod IV over 2.5-3 hours once plus standard of care. Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG003 | 4. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 10 MU/M^2 | Dose level 3: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 10 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
| OG004 | 5. Experimental: Rintatolimod, Recombinant Interferon Alfa-2b 20 MU/M^2 | Dose level 4: Patients receive rintatolimod IV over 2.5-3 hours plus recombinant interferon alfa-2b IV 20 MU/M^2 over 20 minutes on day 1 and on day 3 (or 4) in the absence of disease progression or unacceptable toxicity. Biological/Vaccine: Recombinant Interferon Alfa-2b Given IV Other Names: Alfatronol Glucoferon Heberon Alfa IFN alpha-2B Interferon alfa 2b Interferon Alfa-2B Interferon Alpha-2b Intron A recombinant interferon alfa-2b Sch 30500 Urifron Viraferon Drug: Rintatolimod Given IV Other Names: Ampligen Atvogen RINTATOLIMOD |
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