Vaccine Therapy in Treating Patients With Malignant Glioma
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.
Brain and Central Nervous System Tumors
Biological: glioma-associated antigen peptide-pulsed autologous dendritic cell vaccine
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of Glioma-Associated Antigen (GAA) Peptide-pulsed Dendritic Cell Vaccination in Malignant Glioma Patients|
- Dose-limiting toxicity and maximum tolerated dose of autologous dendritic cells pulsed with synthetic glioma-associated antigen (GAA) peptides [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Tumor progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||May 2006|
|Study Completion Date:||October 2012|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
|Experimental: dendritic cell vaccine||Biological: glioma-associated antigen peptide-pulsed autologous dendritic cell vaccine|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|