HLA-A2-Restricted Glioma Antigen-Peptides Vaccinations With Poly-ICLC for Recurrent WHO Grade II Gliomas
This is a pilot vaccine study in adults with recurrent WHO Grade II gliomas. The purpose of this study is to test the safety and efficacy of an experimental tumor vaccine made from peptides in combination with the study drug Poly-ICLC.
Poly-ICLC, manufactured by Oncovir, Inc., has already been received and is generally well tolerated by subjects in earlier studies and has been shown to decrease the size of brain tumors in some cases.
The immunological and safety data will be used to decide whether a larger study of clinical efficacy is warranted.
|Astrocytoma Oligoastrocytoma Oligodendroglioma||Biological: Peptide vaccine + Poly-ICLC||Early Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Pilot Study to Evaluate the Effects of Vaccinations With HLA-A2-Restricted Glioma Antigen-Peptides in Combination With Poly-ICLC for Adults With Recurrent WHO Grade II Gliomas|
- Both immunological and safety data will serve as bases to decide whether a larger follow-up study is warranted. [ Time Frame: 4 years ]
- Clinical response: 6 month and 2-year progression-free survival (PFS) will be evaluated based on serial magnetic resonance imaging (MRI) scans. [ Time Frame: 4 years ]
- Tumor tissues for biological correlates: for patients who develop progression, biopsy/resection will be encouraged and analyzed for GAA expression status and infiltration of GAA-specific T-cells [ Time Frame: 4 ]
|Study Start Date:||April 2009|
|Study Completion Date:||November 2013|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Experimental: Vaccine + Poly-ICLC
Peptide Vaccine + Poly-ICLC
Biological: Peptide vaccine + Poly-ICLC
Subcutaneously in right or left upper arms with intact draining axillary nodes. Each will be injected to the same location in the same arm as the previous vaccine was administered. In case of no intact axillary lymph nodes as draining nodes, vaccines will be administered in the upper thigh on the same side with intact inguinal lymph nodes.
Vaccine will be administered on weeks 0,3,6,9,12,15,18 and 21. Poly-ICLC First course(20 mg/kg i.m., up to 1640 µg/injection) will be administered on an outpatient basis in the Clinical & Translational Research Center (CTRC)the day of the first GAA/TT-vaccine and on day 4 after the vaccine. For each of the repeated vaccinations (on Weeks 3,6,9,12,15,18 and 21) poly-ICLC will be administered on day of the vaccine and on day 4 after the vaccine.
This is a pilot study of a vaccination regime that is designed to efficiently induce anti-tumor T-cell responses in patients with recurrent WHO grade II glioma. The proposed regime combines subcutaneous injections of glioma-associated antigen (GAA)-derived cytotoxic T-lymphocyte (CTL) epitope-peptides with simultaneous intramuscular (i.m.) administration of poly-ICLC.
The overall objective of this pilot study is to collect immunological and safety data that will be used to decide whether a larger study of clinical efficacy is warranted in these patients. All patients on the study will be followed for a minimum of 2 years, so that the actual 2-year overall survival (OS), 6-month and 2-year progression-free survival (PFS) rates can be determined in an exploratory manner.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00874861
|United States, Pennsylvania|
|UPMC Hillman Cancer Center (University of Pittsburgh Cancer Institute)|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Frank Lieberman, MD||University of Pittsburgh|