NCT00890032

Vaccine Therapy in Treating Patients Undergoing Surgery for Recurrent Glioblastoma Multiforme

Recurrent GBM Stem Cell Tumor Amplified RNA Immunotherapy Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: John Sampson · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Vaccines made from a person's tumor cells and dendritic cells may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating patients undergoing surgery for recurrent glioblastoma multiforme (GBM).

Detailed description

OBJECTIVES: Primary * To evaluate the feasibility and safety of an autologous brain tumor stem cell messenger ribonucleic acid (mRNA)-loaded dendritic cell vaccine in adult patients with recurrent glioblastoma multiforme. Secondary * To assess humoral and cellular immune responses to vaccination. * To compare the proportion of vaccinated patients alive at 6 months from the time of surgery for recurrent tumor with matched historical cohorts. OUTLINE: Patients undergo surgical resection of tumor. Tumor tissue samples are collected to isolate brain tumor stem cells (BTSCs) and for extraction and amplification of BTSC-specific mRNA. Within 4 weeks after surgical resection, patients undergo leukapheresis over 4 hours to generate dendritic cells (DCs). Patients also undergo leukapheresis at 1 week after the third vaccination and then at least every 3 months as needed for generation of additional DCs. Patients receive autologous BTSC mRNA-loaded DC vaccine intradermally once weekly for 3 weeks and then once monthly in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically.

Conditions

• Recurrent Central Nervous System Neoplasm

Interventions

Type	Name	Description
BIOLOGICAL	BTSC mRNA-loaded DCs	An escalating total dose of BTSC mRNA-loaded DCs (2x10\^6, 5x10\^6, and 2x10\^7 per vaccination) will be evaluated for purpose of establishing a maximum tolerated dose (MTD) and a dose-limiting toxicity (DLT).

Timeline

• Start date: 2009-09-01
• Primary completion: 2014-10-01
• Completion: 2016-02-01
• First posted: 2009-04-29
• Last updated: 2016-10-17

Locations

1 site across 1 country: United States