NCT01204684

Dendritic Cell Vaccine for Patients With Brain Tumors

A Phase II Clinical Trial Evaluating Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen +/- Toll-like Receptor Agonists for the Treatment of Malignant Glioma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to evaluate the most effective immunotherapy vaccine components in patients with malignant glioma. Teh investigators previous phase I study (IRB #03-04-053) already confirmed that this vaccine procedure is safe in patients with malignant brain tumors, and with an indication of extended survival in several patients. However, the previous trial design did not allow us to test which formulation of the vaccine was the most effective. This phase II study will attempt to dissect out which components are most effective together. Dendritic cells (DC) (cells which "present" or "show" cell identifiers to the immune system) isolated from the subject's own blood will be treated with tumor-cell lysate isolated from tumor tissue taken from the same subject during surgery. This pulsing (combining) of antigen-presenting and tumor lysate will be done to try to stimulate the immune system to recognize and destroy the patient's intracranial brain tumor. These pulsed DCs will then be injected back into the patient intradermally as a vaccine. The investigators will also utilize adjuvant imiquimod or poly ICLC (interstitial Cajal-like cell) in some treatment cohorts. It is thought that the host immune system might be taught to "recognize" the malignant brain tumor cells as "foreign" to the body by effectively presenting unique tumor antigens to the host immune cells (T-cells) in vivo.

Conditions

• Glioma
• Anaplastic Astrocytoma
• Anaplastic Astro-oligodendroglioma
• Glioblastoma

Interventions

Type	Name	Description
BIOLOGICAL	autologous tumor lysate-pulsed DC vaccination
BIOLOGICAL	Tumor lysate-pulsed DC vaccination+0.2% resiquimod
BIOLOGICAL	Tumor-lysate pulsed DC vaccination +adjuvant polyICLC

Timeline

• Start date: 2010-10-08
• Primary completion: 2024-08-21
• Completion: 2024-08-21
• First posted: 2010-09-17
• Last updated: 2024-08-28

Locations

1 site across 1 country: United States