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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-00980 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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The primary purpose of this phase II clinical trial is to determine the safety and effect on survival of patients autologous dendritic cells pulsed with autologous tumor lysate as a treatment for low-grade glioma patients. Other goals of this study are to determine if the vaccine can cause an immune response against patients' cancer cells and slow the growth of their brain tumors
PRIMARY OBJECTIVES:
I. To determine the 5-year progression-free survival (PFS), using intradermal injections of autologous dendritic cells harvested from peripheral blood precursors and pulsed (co-cultured) with tumor lysate derived from surgical tissues in patients with low-grade gliomas.
SECONDARY OBJECTIVES:
I. To monitor overall survival (OS), and cellular immune responses in brain tumor patients injected with tumor lysate-pulsed dendritic cells.
OUTLINE:
Patients receive tumor lysate-pulsed autologous dendritic cell vaccine intradermally (ID) on days 0, 14, and 28.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (tumor lysate-pulsed autologous dendritic cells) | Experimental | Patients receive autologous glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on days 0, 14, and 28. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tumor lysate-pulsed autologous dendritic cell vaccine | Biological | Given ID |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) of Low Grade Glioma Patients Treated With Autologous Dendritic Cells Pulsed With Autologous Tumor Lysate | a Kaplan-Meier curve of the PFS of our trial patients was created and compared to the PFS of control patients matched for tumor grade, recurrence number, IDH1 status and 1p/19q status. | Each case was assessed from the baseline date of surgery to MRI evidence of tumor progression through study completion, up to 44 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | From date of enrollment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months. a Kaplan-Meier curve of the OS of our trial patients was created and compared to the OS of control patients matched for tumor grade, recurrence number, IDH1 status and 1p/19q status. | The timeframe for OS was from the date of surgery until the date of death from any cause, up to 44 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Prins | Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | United States |
Study enrollment patients must satisfy inclusion criteria, screening evaluations (vital signs, history, physical, neurological exams, Karnofsky Performance Scale, brain MRI , urinalysis, complete blood count, differential, platelets, coagulation tests), underwent leukapheresis, and had suitable Dendritic Cell (DC) Vaccine manufactured for them.
Dates of recruitment period: 1/2012 - 8/2015 Types of location: Medical clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells) | Patients receive autologous glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on days 0, 14, and 28. tumor lysate-pulsed autologous dendritic cell vaccine: Given ID laboratory biomarker analysis: Correlative studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| laboratory biomarker analysis | Other | Correlative studies |
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| Anti-tumor Immune Responses | Tumor and peripheral blood samples were collected from each of the participants and analyzed for the following biomarkers: IDH1-specific antibodies CD8, PD-1, and PD-L1 content, and correlations among those three biomarkers Mutation analysis/sequencing | Tumor for analysis (CD8, Programmed Death (PD)-1, PD-L1, mutation analysis) was collected at the vaccine-related surgery shortly after enrollment. Blood for analysis (IDH1-specific antibodies) was collected at Day 0, before the first vaccine injection. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells) | Patients receive autologous glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on days 0, 14, and 28. tumor lysate-pulsed autologous dendritic cell vaccine: Given ID laboratory biomarker analysis: Correlative studies |
| 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 and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | 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 | Progression-free Survival (PFS) of Low Grade Glioma Patients Treated With Autologous Dendritic Cells Pulsed With Autologous Tumor Lysate | a Kaplan-Meier curve of the PFS of our trial patients was created and compared to the PFS of control patients matched for tumor grade, recurrence number, IDH1 status and 1p/19q status. | Completed the maximum time allowed on study without being affected by Tumor Recurrence or Progression. | Posted | Number | participants | Each case was assessed from the baseline date of surgery to MRI evidence of tumor progression through study completion, up to 44 months. |
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| Secondary | Overall Survival (OS) | From date of enrollment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months. a Kaplan-Meier curve of the OS of our trial patients was created and compared to the OS of control patients matched for tumor grade, recurrence number, IDH1 status and 1p/19q status. | Posted | Count of Participants | Participants | The timeframe for OS was from the date of surgery until the date of death from any cause, up to 44 months. |
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| Secondary | Anti-tumor Immune Responses | Tumor and peripheral blood samples were collected from each of the participants and analyzed for the following biomarkers: IDH1-specific antibodies CD8, PD-1, and PD-L1 content, and correlations among those three biomarkers Mutation analysis/sequencing | Quantitative multiplex immuno-histochemical (IHC) of pre-treatment glioma microenvironment of IDH1-specific antibodies | Posted | Mean | Standard Deviation | percentage of cells per field | Tumor for analysis (CD8, Programmed Death (PD)-1, PD-L1, mutation analysis) was collected at the vaccine-related surgery shortly after enrollment. Blood for analysis (IDH1-specific antibodies) was collected at Day 0, before the first vaccine injection. |
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The timeframe for adverse event reporting was from the day of the first vaccine treatment until the patient discontinued the study for any reason, up to 44 months.
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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 | Treatment (Tumor Lysate-pulsed Autologous Dendritic Cells) | Patients receive autologous glioma tumor lysate-pulsed autologous dendritic cell vaccine ID on days 0, 14, and 28. tumor lysate-pulsed autologous dendritic cell vaccine: Given ID laboratory biomarker analysis: Correlative studies | 0 | 5 | 0 | 5 | 3 | 5 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Seizure | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Dysphasia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Visual Distortions | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| cognitive slowness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Fractures | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Squamous cell carcinomas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Non-systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
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| Upper respritory infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Headache | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Rhinorrhea | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Prins | Jonsson Comprehensieve Cancer Center | 310-825-7647 | rprins@mednet.ucla.edu |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D009837 | Oligodendroglioma |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| 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 |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Title | Measurements |
|---|---|
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| 19-24 months |
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| 25-30 months |
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| >30 months |
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