Phase I Dose Escalation Study of Autologous Tumor Lysate-Pulsed Dendritic Cell Immunotherapy for Malignant Gliomas
- Determine the dose-limiting toxicity and maximum tolerated dose of autologous tumor
lysate-pulsed dendritic cells in patients with malignant gliomas.
- Determine survival, tumor progression, and cellular immune response in patients treated
with this regimen.
OUTLINE: This is a dose-escalation study.
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 and pulsed with autologous tumor lysate. Patients
receive autologous tumor lysate-pulsed DC intradermally on days 0, 14, and 28 in the absence
of unacceptable toxicity.
Cohorts of 6-12 patients receive escalating doses of autologous tumor lysate-pulsed DC until
the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding
that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 2 months for 2 years.
PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study within 9-18
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Dose Limiting Toxicity
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|