Vaccine Therapy in Treating Patients With Malignant Glioma
|ClinicalTrials.gov Identifier: NCT00612001|
Recruitment Status : Completed
First Posted : February 11, 2008
Last Update Posted : October 5, 2015
RATIONALE: Vaccines made from peptides and a person's dendritic cells may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with malignant glioma.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Biological: glioma-associated antigen peptide-pulsed autologous dendritic cell vaccine||Phase 1|
- Determine the dose-limiting toxicity and maximum tolerated dose of autologous dendritic cells pulsed with synthetic glioma-associated antigen (GAA) peptides in patients with malignant gliomas.
- Determine survival, tumor progression, and cellular immune response in patients treated with this regimen.
OUTLINE: Patients undergo leukapheresis for the collection of peripheral blood mononuclear cells (PBMC). Autologous dendritic cells (DC) are prepared from autologous PBMC exposed to sargramostim (GM-CSF) and interleukin-4 (IL-4), matured with a cytokine cocktail, and pulsed with synthetic glioma-associated antigen (GAA) peptides. Cohorts of patients receive escalating doses of GAA peptide-pulsed autologous dendritic cell vaccine until the maximum tolerated dose is determined.
After completion of study treatment, patients are followed every 2 months for 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Glioma-Associated Antigen (GAA) Peptide-pulsed Dendritic Cell Vaccination in Malignant Glioma Patients|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||October 2012|
|Experimental: dendritic cell vaccine||
Biological: glioma-associated antigen peptide-pulsed autologous dendritic cell vaccine
- Dose-limiting toxicity and maximum tolerated dose of autologous dendritic cells pulsed with synthetic glioma-associated antigen (GAA) peptides [ Time Frame: 3 months ]
- Survival [ Time Frame: 1 year ]
- Tumor progression [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00612001
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095-1781|
|Principal Investigator:||Linda M. Liau, MD, PhD||Jonsson Comprehensive Cancer Center|