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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA175517 | U.S. NIH Grant/Contract | View source | |
| OCR14127 | Other Identifier | Universiy of Florida |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The purpose of this research study is to determine if an investigational dendritic cell vaccine, called pp65 DC, is effective for the treatment of a specific type of brain tumor called glioblastoma (GBM) when given with stronger doses of routine chemotherapy.
Dendritic cells (DC) are involved in activating, or turning-on, your body's immune system. Your immune system helps guard your body from germs, viruses, and other threats. Although dendritic cells are very strong, the number of them in the body is not high enough to cause a powerful immune response; therefore, more DC are made in a laboratory with cells collected from an individual's blood.
In this study, we will make a vaccine that we hope will educate immune cells to target the pp65 antigen, a type of immune marker in GBM, thus resulting in what we call the pp65 DC vaccine. Use of a vaccine that activates your immune system is a type of immunotherapy. It is hoped that by giving the pp65 DC vaccine as a shot under the skin, the immune system will be activated to attack tumor cells in the brain while leaving normal cells alone.
To see if the pp65 DC vaccine is effective for the treatment of GBM, subjects will be assigned to different treatment groups. Two groups of subjects will receive the pp65 DC vaccine and one group will receive a placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: pp65-shLAMP DC with GM-CSF and Td | Experimental | Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity. |
|
| Arm 2: pp65-flLAMP DC with GM-CSF and Td | Experimental | Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity. |
|
| Arm 3: unpulsed PBMC and Saline | Placebo Comparator | Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pp65-shLAMP DC with GM-CSF | Biological |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Overall Survival (OS) Between the Active Treatment Group (Arms 1 and 2) and the Control Group (Arm 3) | Kaplan-Meier survival curves and the log rank test will be used to characterize and compare OS in patients who received pp65-LAMP mRNA DC vaccine (Arms 1 and 2) and in control patients (Arm 3). OS will be defined as the time between first vaccination and death and will be censored at the last follow-up if death has not occurred. | From date of first vaccine until the date of death, up to 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Progression-free Survival Between the Active Treatment Group (Arms 1 and 2 Combined) and the Control Group (Arm 3) | Calculated as dated of first vaccine to date first progression/recurrence or death. Kaplan-Meier survival curves and the log rank test will be used to characterize and compare PFS in patients who received pp65-LAMP mRNA DC vaccine (Arms 1 and 2) and in control patients (Arm 3). PFS is defined as the time between first vaccination and first documentation of either disease progression/recurrence, or death without prior progression/recurrence. |
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Abbreviated Inclusion Criteria:
To be assessed at study enrollment prior to standard of care chemo-radiation therapy:
To be assessed prior to initiation of adjuvant TMZ:
Abbreviated Exclusion Criteria:
To be verified in order to randomize subject:
To be assessed prior to initiation of adjuvant TMZ:
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| Name | Affiliation | Role |
|---|---|---|
| Duane Mitchell, MD, PhD | University of Florida | Study Chair |
| Maryam Rahman, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States | ||
| Orlando Health |
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Participants were evaluated for inclusion. 17 were determined not eligible and 4 participants withdrew. 154 participants were randomized with an allocation ratio of 1:1:1 into one of three arms: 1) Arm 1: pp65-shLAMP mRNA DCs with GM-CSF 150 µg (Td skin prep); 2) Arm 2: pp65-flLAMP mRNA DCs with GM-CSF 150 µg (Td skin prep); or 3) Arm 3: Unpulsed PBMCs (saline skin prep).
175 participants were enrolled (consented) between 8/9/2016 and 10/5/2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | pp65-shLAMP DC With GM-CSF and Td (Arm 1) | Prior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms. Experimental Arm 1 pp65-shLAMP DC with GM-CSF and Td DC vaccines are given under the skin at day 22-24 after the first temozolomide cycle then at 2-week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity. Td: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9. |
| 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 | Oct 7, 2024 |
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| unpulsed PBMC and saline | Biological |
|
|
| Td | Drug | All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9. |
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|
| Saline | Drug |
|
|
| pp65-flLAMP DC with GM-CSF | Biological |
|
|
| From date of first vaccine until time disease progression or death without prior progression/recurrence, up to 48 months |
| ELISPOT Assay (pp65) | Within patient changes from baseline to vaccine 3. | baseline, post-vaccine #3 |
| Flow Cytometric Analysis (T Cell) | Percentage of circulating cellular subsets of T cells within PBMCs. | baseline, post-vaccine #3 |
| Cytokine Array Analysis (IFN-g) | Change in concentration (pg/mL) of IFN-g as measured by multiplex array from Baseline (V1) to post-Vaccine #3. | baseline, post-vaccine #3 |
| ELISPOT Assay (Actin) | Within patient changes from baseline to vaccine 3. | baseline, post-vaccine #3 |
| Flow Cytometric Analysis (NK Cell) | Percentage of circulating cellular subsets of NK cells within PBMCs. | baseline, post-vaccine #3 |
| Flow Cytometric Analysis (CD4.CD25 T Reg) | Percentage of circulating cellular subsets of CD4.CD25 T Reg within PBMCs. | baseline, post-vaccine #3 |
| Orlando |
| Florida |
| 32806 |
| United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| FG001 | pp65-flLAMP DC With GM-CSF and Td (Arm 2) | Prior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms. Experimental Arm 2 pp65-flLAMP DC with GM-CSF and Td DC vaccines are given under the skin at day 22-24 after the first temozolomide cycle then at 2-week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity. Td: All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9. |
| FG002 | Unpulsed PBMC and Saline (Arm 3) | The control group was Arm 3, Unpulsed PBMCs (saline skin prep) Prior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms. |
| COMPLETED |
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| NOT COMPLETED |
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All subjects who received at least one DC vaccine were included in the modified intent to treat analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | pp65-shLAMP DC With GM-CSF and Td (Arm 1) | The active treatment group were Arms 1 and 2 Arm 1: pp65-shLAMP mRNA DCs with GM-CSF 150 µg (Td skin prep) Prior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms. |
| BG001 | pp65-flLAMP DC With GM-CSF and Td (Arm 2) | The active treatment group were Arms 1 and 2 Arm 2: pp65-flLAMP mRNA DCs with GM-CSF 150 µg (Td skin prep) Prior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms. |
| BG002 | Unpulsed PBMC and Saline (Arm 3) | The control group was Arm 3, Unpulsed PBMCs (saline skin prep) Prior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Comparison of Overall Survival (OS) Between the Active Treatment Group (Arms 1 and 2) and the Control Group (Arm 3) | Kaplan-Meier survival curves and the log rank test will be used to characterize and compare OS in patients who received pp65-LAMP mRNA DC vaccine (Arms 1 and 2) and in control patients (Arm 3). OS will be defined as the time between first vaccination and death and will be censored at the last follow-up if death has not occurred. | Survival in Patients receiving vaccine vs placebo. | Posted | Median | 95% Confidence Interval | months | From date of first vaccine until the date of death, up to 48 months |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Comparison of Progression-free Survival Between the Active Treatment Group (Arms 1 and 2 Combined) and the Control Group (Arm 3) | Calculated as dated of first vaccine to date first progression/recurrence or death. Kaplan-Meier survival curves and the log rank test will be used to characterize and compare PFS in patients who received pp65-LAMP mRNA DC vaccine (Arms 1 and 2) and in control patients (Arm 3). PFS is defined as the time between first vaccination and first documentation of either disease progression/recurrence, or death without prior progression/recurrence. | Progression free survival in patients receiving vaccine vs placebo. | Posted | Median | 95% Confidence Interval | months | From date of first vaccine until time disease progression or death without prior progression/recurrence, up to 48 months |
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| Secondary | ELISPOT Assay (pp65) | Within patient changes from baseline to vaccine 3. | Participants in each arm who received at least 3 DC vaccines. | Posted | Mean | Standard Deviation | spot forming units (SFU) | baseline, post-vaccine #3 |
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| Secondary | Flow Cytometric Analysis (T Cell) | Percentage of circulating cellular subsets of T cells within PBMCs. | Only participants who received at least 3 DC vaccines are included. | Posted | Mean | Standard Deviation | percentage of PBMC | baseline, post-vaccine #3 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cytokine Array Analysis (IFN-g) | Change in concentration (pg/mL) of IFN-g as measured by multiplex array from Baseline (V1) to post-Vaccine #3. | Only participants who received at least 3 DC vaccines are included in the analysis | Posted | Mean | Standard Deviation | pg/mL | baseline, post-vaccine #3 |
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| Secondary | ELISPOT Assay (Actin) | Within patient changes from baseline to vaccine 3. | Participants in each arm who received at least 3 DC vaccines. | Posted | Mean | Standard Deviation | spot forming units (SFU) | baseline, post-vaccine #3 |
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| Secondary | Flow Cytometric Analysis (NK Cell) | Percentage of circulating cellular subsets of NK cells within PBMCs. | Only participants who received at least 3 DC vaccines are included. | Posted | Mean | Standard Deviation | percentage of PBMC | baseline, post-vaccine #3 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Flow Cytometric Analysis (CD4.CD25 T Reg) | Percentage of circulating cellular subsets of CD4.CD25 T Reg within PBMCs. | Only participants who received at least 3 DC vaccines are included. | Posted | Mean | Standard Deviation | percentage of PBMC | baseline, post-vaccine #3 |
|
AE collection began at the time of administration of vaccine #1 and continued until 30 days after the last dose of study drug, up to 13 months for each participant. All-cause mortality was assessed up to 48 months.
The reporting of Adverse Events is based on the efficacy analysis set (mITT), which includes all subjects who receive at least one DC vaccine. 111 participants were included in modified intent to treat; for purposes of AE reporting, the N was 110 after we excluded 1 participant who did not meet AE reporting criteria.
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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 | pp65-shLAMP DC With GM-CSF and Td (Arm 1) | The active treatment group was arms 1 and 2 combined. Arm 1: pp65-shLAMP mRNA DCs with GM-CSF 150 µg (Td skin prep) Arm 2: pp65-flLAMP mRNA DCs with GM-CSF 150 µg (Td skin prep) | 28 | 36 | 8 | 36 | 16 | 36 |
| EG001 | pp65-flLAMP DC With GM-CSF and Td (Arm 2) | The active treatment group was arms 1 and 2 combined. Arm 1: pp65-shLAMP mRNA DCs with GM-CSF 150 µg (Td skin prep) Arm 2: pp65-flLAMP mRNA DCs with GM-CSF 150 µg (Td skin prep) | 31 | 34 | 6 | 34 | 11 | 34 |
| EG002 | Unpulsed PBMC and Saline (Arm 3) | The control group was Arm 3, Unpulsed PBMCs (saline skin prep) Prior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms. | 31 | 41 | 5 | 41 | 13 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bruising | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Gastrointestinal - Other (Specify, appendicitis) | Gastrointestinal disorders | Non-systematic Assessment |
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| Hematoma | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Infection | Infections and infestations | Non-systematic Assessment |
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| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Muscle weakness, generalized or specific area (not due to neuropathy) - Left-sided | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| CNS cerebrovascular ischemia | Nervous system disorders | Non-systematic Assessment |
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| Hydrocephalus | Nervous system disorders | Non-systematic Assessment |
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| Neurology - Other (Specify, cerebral edema) | Nervous system disorders | Non-systematic Assessment |
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| Seizure | Nervous system disorders | Non-systematic Assessment |
| ||
| Syncope (fainting) | Nervous system disorders | Non-systematic Assessment |
| ||
| Aspiration | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Thrombosis/thrombus/embolism | Vascular disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CD4 Count | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Lymphopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Neutrophils/granulocytes | Blood and lymphatic system disorders | Systematic Assessment |
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| Platelets | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Hypertension | Cardiac disorders | Systematic Assessment |
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| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General disorders | Non-systematic Assessment |
| ||
| Bruising | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Gastrointestinal - Other | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Hematoma | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Infections and infestations | Non-systematic Assessment |
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| Infection - Other | Infections and infestations | Non-systematic Assessment |
| ||
| Infection with normal ANC or Grade 1 or 2 neutrophils - Kidney | Infections and infestations | Non-systematic Assessment |
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| Opportunistic infection associated with >=Grade 2 Lymphopenia | Infections and infestations | Non-systematic Assessment |
| ||
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Muscle weakness, generalized or specific area (not due to neuropathy) - Left-sided | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| CNS cerebrovascular ischemia | Nervous system disorders | Non-systematic Assessment |
| ||
| Hydrocephalus | Nervous system disorders | Non-systematic Assessment |
| ||
| Mood alteration - Depression | Nervous system disorders | Non-systematic Assessment |
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| Neurology - Other | Nervous system disorders | Non-systematic Assessment |
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| Pyramidal tract dysfunction | Nervous system disorders | Non-systematic Assessment |
| ||
| Seizure | Nervous system disorders | Non-systematic Assessment |
| ||
| Syncope (fainting) | Nervous system disorders | Non-systematic Assessment |
| ||
| Pain - Head/headache | General disorders | Non-systematic Assessment |
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| Aspiration | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Thrombosis/thrombus/embolism | Vascular disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Duane Mitchell, MD, PhD | University of Florida | 352-273-9000 | duane.mitchell@neurosurgery.ufl.edu |
| Oct 31, 2024 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 21, 2021 | Mar 22, 2024 | ICF_000.pdf |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D005910 | Glioma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| D016178 | Granulocyte-Macrophage Colony-Stimulating Factor |
| D012965 | Sodium Chloride |
| D013745 | Tetanus Toxoid |
| D004168 | Diphtheria Toxoid |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| 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 |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Hazard Ratio (HR) |
| 1.63 |
| 2-Sided |
| 95 |
| 0.99 |
| 2.70 |
| Superiority |
| OG002 | Unpulsed PBMC and Saline (Arm 3) | Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity. unpulsed PBMC and saline Saline |
|
|
|
Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity. unpulsed PBMC and saline Saline |
|
|
|
| OG002 | Unpulsed PBMC and Saline (Arm 3) | The control group was Arm 3, Unpulsed PBMCs (saline skin prep) Prior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms. |
|
|
| OG002 | Unpulsed PBMC and Saline (Arm 3) | The control group was Arm 3, Unpulsed PBMCs (saline skin prep) Prior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms. |
|
|
|
Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity. unpulsed PBMC and saline Saline |
|
|
|
| OG002 | Unpulsed PBMC and Saline (Arm 3) | The control group was Arm 3, Unpulsed PBMCs (saline skin prep) Prior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms. |
|
|
| OG002 | Unpulsed PBMC and Saline (Arm 3) | The control group was Arm 3, Unpulsed PBMCs (saline skin prep) Prior to leukapheresis, patients will be randomized to receive one of three treatment regimens with dose-intensified TMZ treatment at 100 mg/m2/day for 21 days with an allocation ratio of 1:1:1 into one of three arms. |
|
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