Spots Global Cancer Trial Database for Vaccine Therapy in Treating Patients With Malignant Glioma

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Trial Identification

Brief Title: Vaccine Therapy in Treating Patients With Malignant Glioma

Official Title: Phase I Study of Glioma-Associated Antigen (GAA) Peptide-pulsed Dendritic Cell Vaccination in Malignant Glioma Patients

Study ID: NCT00612001

Conditions

Brain and Central Nervous System Tumors

Interventions

glioma-associated antigen peptide-pulsed autologous dendritic cell vaccine

Study Description

Brief Summary: 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.

Detailed Description: OBJECTIVES: * 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.