Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase I Study of Glioma-Associated Antigen (GAA) Peptide-pulsed Dendritic Cell Vaccination in Malignant Glioma Patients
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.
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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