drugset / Trial / NCT00795457
Effects of Vaccinations With HLA-A2-Restricted Glioma Antigen-Peptides in Combination With Poly-ICLC for Adults With High-Risk WHO Grade II Astrocytomas and Oligo-Astrocytomas
Phase 0
Completed
13 enrolled
Ian F. Pollack, M.D.
National Cancer Institute (NCI) · collabOncovir, Inc. · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a pilot vaccine study in adults with either WHO grade II astrocytoma, oligoastrocytoma or oligodendroglioma. The purpose of this study is test the safety and efficacy of an experimental tumor vaccine made from peptides and Montanide ISA-51 in combination with the study drug Poly-ICLC. Poly-ICLC, manufactured by Oncovir, Inc., has already been received and 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 in each of two patient cohorts.
Timeline
- Start
- 2009-01
- Primary completion
- 2013-02
- Completion
- 2015-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GAA/TT-peptide vaccine | Vaccine | — | Subcutaneous |
| Subject | Hiltonol | Other / unclassified | 20 mg/kg | Intramuscular |