Dendritic Cell Vaccine for Patients With Brain Tumors

Phase 2

Completed

• Conditions: Glioblastoma; Anaplastic Astro-oligodendroglioma; Glioma; Anaplastic Astrocytoma
• Interventions: Biological: Tumor lysate-pulsed DC vaccination+0.2% resiquimod; Biological: autologous tumor lysate-pulsed DC vaccination; Biological: Tumor-lysate pulsed DC vaccination +adjuvant polyICLC

• Registration Number: NCT01204684
• Lead Sponsor: Jonsson Comprehensive Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-16
• Study First Submitted QC: 2010-09-16
• Study First Posted: 2010-09-17
• Study Start: 2010-10-08
• Status Verified: 2024-08
• Primary Completion: 2024-08-21
• Study Completion: 2024-08-21
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tumor lysate-pulsed DC vaccination+0.2% resiquimod.	Tumor lysate-pulsed DC vaccination+0.2% resiquimod	Cohort #2 will receive autologous tumor lysate-pulsed DC vaccination together with adjuvant 0.2% resiquimod.
Tumor Lysate-pulsed DC vaccination	autologous tumor lysate-pulsed DC vaccination	Cohort #1 will receive autologous tumor lysate-pulsed DC vaccination together with a placebo cream or intramuscular injection of saline.
Tumor-lysate pulsed DC vaccination +adjuvant polyICLC.	Tumor-lysate pulsed DC vaccination +adjuvant polyICLC	Cohort #3 will receive autologous tumor lysate-pulsed DC vaccination together with adjuvant poly ICLC (TLR3 agonist).

Primary Outcome Measures

Name	Time	Method
Most effective combination of DC vaccine components	6 weeks

Secondary Outcome Measures

Name	Time	Method
Time to tumor progression and overall survival	2 years

Trial Locations

Locations (1)

University of Los Angeles, California; 🇺🇸 Los Angeles, California, United States