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| ID | Type | Description | Link |
|---|---|---|---|
| P50CA096888 | U.S. NIH Grant/Contract | View source | |
| P30CA006973 | U.S. NIH Grant/Contract | View source | |
| NA_00035358 | Other Identifier | JHMIRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing. Vaccines made from another person's cancer cells may help the body build an effective immune response to kill cancer cells. Giving rituximab together with chemotherapy and vaccine therapy may kill more cancer cells
PURPOSE: This phase I/II trial is studying how well giving rituximab together with cyclophosphamide and vaccine therapy works in treating patients with relapsed Hodgkin lymphoma.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label study.
Patients receive rituximab IV on days -10 and -7 and then on days 29, 36, 43, and 50 (weeks 4-7) and high-dose (transplant-dose) cyclophosphamide IV on days -3 to 0 without stem cell rescue. Patients receive filgrastim (G-CSF) subcutaneously once daily beginning on day 6 and continuing until blood counts recover. Patients also receive vaccine therapy comprising an allogeneic vaccine that expresses Hodgkin's tumor antigens and sargramostim (GM-CSF) (KGEL vaccine) intradermally on day 1, and weeks 4, 8, 12, 16, and 24.
After completion of high-dose cyclophosphamide, patients are followed every 3 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunotherapy | Experimental | All participants received two days of rituximab, then four days of high-dose cyclophosphamide followed by filgrastim. Participants then received six doses of KGEL vaccine over 24 weeks interspersed with four additional doses of rituximab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KGEL vaccine | Biological | Vaccine was administered at weeks 0, 4, 8, 12, 16, and 24 at a dose of 1 x 10^8 cells per dose. The first dose was given on Day +1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Grade 3-5 Adverse Events | Number of participants who experienced at least one grade 3-5 adverse event by CTCAE 3.0 that was attributed to protocol intervention. | Up to 36 months |
| Percentage of Participants With an Increase in Frequency of LMP2-specific CD8+ T Cells | Percentage of participants with an increase in frequency of LMP2-specific CD8+ T cells. Increase in frequency is defined as at least one order of magnitude higher than baseline measurement. | Change from 3 months to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Median number of months that participants were alive (overall survival) and alive without disease relapse or new diagnosis of myelodysplasia or acute leukemia (event-free survival). | Up to 6 years |
| Days to Neutrophil and Platelet Engraftment |
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DISEASE CHARACTERISTICS:
Histologically confirmed classical Hodgkin's lymphoma
Relapsed disease with achievement of at least a partial response or a metabolic response to most recent salvage therapy
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| Richard Ambinder, MD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231-2410 | United States |
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One participant was a screen failure.
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| ID | Title | Description |
|---|---|---|
| FG000 | Immunotherapy | All participants received two days of rituximab, then four days of high-dose cyclophosphamide followed by filgrastim. Participants then received six doses of KGEL vaccine over 24 weeks interspersed with four additional doses of rituximab. KGEL vaccine: Vaccine was administered at weeks 0, 4, 8, 12, 16, and 24 at a dose of 1 x 10^8 cells per dose. The first dose was given on Day +1. Filgrastim: 5 mcg/kg/day starting on Day +6 until ANC is >= 1000/mcL. Rituximab: 375 mg/m^2/day on Days -10, -7, and at weeks 4, 5, 6, and 7. Cyclophosphamide: 50 mg/kg/day on Day -3, -2, -1, and 0. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Immunotherapy | All participants received two days of rituximab, then four days of high-dose cyclophosphamide followed by filgrastim. Participants then received six doses of KGEL vaccine over 24 weeks interspersed with four additional doses of rituximab. KGEL vaccine: Vaccine was administered at weeks 0, 4, 8, 12, 16, and 24 at a dose of 1 x 10^8 cells per dose. The first dose was given on Day +1. Filgrastim: 5 mcg/kg/day starting on Day +6 until ANC is >= 1000/mcL. Rituximab: 375 mg/m^2/day on Days -10, -7, and at weeks 4, 5, 6, and 7. Cyclophosphamide: 50 mg/kg/day on Day -3, -2, -1, and 0. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Grade 3-5 Adverse Events | Number of participants who experienced at least one grade 3-5 adverse event by CTCAE 3.0 that was attributed to protocol intervention. | Posted | Count of Participants | Participants | Up to 36 months |
|
Up to 3 years
The following adverse events only were collected on this study:
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immunotherapy | All participants received two days of rituximab, then four days of high-dose cyclophosphamide followed by filgrastim. Participants then received six doses of KGEL vaccine over 24 weeks interspersed with four additional doses of rituximab. KGEL vaccine: Vaccine was administered at weeks 0, 4, 8, 12, 16, and 24 at a dose of 1 x 10^8 cells per dose. The first dose was given on Day +1. Filgrastim: 5 mcg/kg/day starting on Day +6 until ANC is >= 1000/mcL. Rituximab: 375 mg/m^2/day on Days -10, -7, and at weeks 4, 5, 6, and 7. Cyclophosphamide: 50 mg/kg/day on Day -3, -2, -1, and 0. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Investigations | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Ambinder, MD | Johns Hopkins University | 4109558839 | rambind1@jhmi.edu |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| Filgrastim | Biological | 5 mcg/kg/day starting on Day +6 until ANC is >= 1000/mcL. |
|
|
| Rituximab | Biological | 375 mg/m^2/day on Days -10, -7, and at weeks 4, 5, 6, and 7. |
|
|
| Cyclophosphamide | Drug | 50 mg/kg/day on Day -3, -2, -1, and 0. |
|
|
Median number of days to absolute neutrophil count (ANC) >= 500/mcL and platelet count >=20000/mcL. |
| Up to 46 days |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Percentage of Participants With an Increase in Frequency of LMP2-specific CD8+ T Cells | Percentage of participants with an increase in frequency of LMP2-specific CD8+ T cells. Increase in frequency is defined as at least one order of magnitude higher than baseline measurement. | Although the specimens were collected per protocol, they were not interpretable and therefore no data was collected to assess this outcome measure | Posted | Change from 3 months to 6 months |
|
|
| Secondary | Survival | Median number of months that participants were alive (overall survival) and alive without disease relapse or new diagnosis of myelodysplasia or acute leukemia (event-free survival). | Posted | Median | Full Range | months | Up to 6 years |
|
|
|
| Secondary | Days to Neutrophil and Platelet Engraftment | Median number of days to absolute neutrophil count (ANC) >= 500/mcL and platelet count >=20000/mcL. | Posted | Median | Full Range | days | Up to 46 days |
|
|
|
| 1 |
| 30 |
| 15 |
| 30 |
| 30 |
| 30 |
| Influenza A | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea and vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Febrile neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Cytopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Rigors | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - back | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombus | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection, not specified | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bruising | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Headache | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Injection site reaction | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Leukopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Lymphopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neutropenia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Pain - knee | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - thigh | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombocytopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Weakness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Xerosis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |