Phase I Study of Glioma-Associated Antigen (GAA) Peptide-pulsed Dendritic Cell Vaccination in Malignant Glioma Patients
- Determine the dose-limiting toxicity and maximum tolerated dose of autologous dendritic
cells pulsed with synthetic glioma-associated antigen (GAA) peptides in patients with
- 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.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose-limiting toxicity and maximum tolerated dose of autologous dendritic cells pulsed with synthetic glioma-associated antigen (GAA) peptides
Linda M. Liau, MD, PhD
Jonsson Comprehensive Cancer Center
United States: Food and Drug Administration
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|