Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase I Dose Escalation Study of Autologous Tumor Lysate-Pulsed Dendritic Cell Immunotherapy for Malignant Gliomas
RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may make
the body build an 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 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
months.
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