Vaccine Therapy in Treating Young Patients Who Are Undergoing Surgery for Malignant Glioma
RATIONALE: Vaccines made from a person's white blood cells and tumor cells may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy after surgery may be a more effective treatment for malignant glioma.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating young patients who are undergoing surgery for malignant glioma.
Brain and Central Nervous System Tumors
Biological: therapeutic autologous dendritic cells
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Dose Escalation Study of Autologous Tumor Lysate-Pulsed Dendritic Cell Immunotherapy for Malignant Gliomas in Pediatric Patients|
- Dose-limiting toxicity of adjuvant vaccination with autologous tumor lysate-pulsed dendritic cells after surgical resection in pediatric patients with malignant glioma. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]survival with this vaccine
- time to progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||January 2005|
|Study Completion Date:||March 2010|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
|Experimental: Vaccine||Biological: therapeutic autologous dendritic cells|
- Determine the dose-limiting toxicity of adjuvant vaccination with autologous tumor lysate-pulsed dendritic cells after surgical resection in pediatric patients with malignant glioma.
- Determine the maximum tolerated dose of this vaccine in these patients.
- Determine, preliminarily, the survival of patients treated with this vaccine.
- Determine, preliminarily, the time to tumor progression in patients treated with this vaccine.
- Determine cellular immune response in patients treated with this vaccine.
- Determine age-dependent differences in response to this vaccine, in terms of immunocompetence, in these patients.
OUTLINE: This is a dose-escalation study.
Patients undergo surgical resection to obtain tumor tissue for production of tumor lysate. Patients then undergo leukapheresis to obtain peripheral blood mononuclear cells (PBMC) for generation of dendritic cells (DC). DC are pulsed with tumor lysate to produce an autologous dendritic cell vaccine. Approximately 10-30 days after leukapheresis, patients receive vaccination with autologous tumor lysate-pulsed dendritic cells intradermally on days 0, 14, and 28 in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of vaccine 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.
After completion of study treatment, patients are followed at 2 weeks and then every 2 months for 1 year.
PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study within 2-4.5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00107185
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095-1781|
|Principal Investigator:||Joseph L. Lasky, MD||Jonsson Comprehensive Cancer Center|