NCT00068510

Vaccine Therapy in Treating Patients With Malignant Glioma

Phase I Dose Escalation Study of Autologous Tumor Lysate-Pulsed Dendritic Cell Immunotherapy for Malignant Gliomas

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
BIOLOGICAL	therapeutic autologous dendritic cells

Timeline

• Start date: 2003-06-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2003-09-11
• Last updated: 2020-08-03

Locations

1 site across 1 country: United States