HSPPC-96 Vaccine With Temozolomide in Patients With Newly Diagnosed GBM (HeatShock)May 8th, 2012 | Posted by in Clinical Trials | Newly Diagnosed
The HSPPC-96 brain tumor-specific vaccine has extended survival rates by two to three times in early-stage trials. The vaccine is made using a heat shock protein (produced by the patient’s immune system) harvested from the tumor itself. An adjuvant, or an agent that increases the immunological effect of the protein, is added to the heat shock protein, and the combination is re-injected into the skin. The mixture stimulates the body’s immune system to attack cancer cells. The vaccine is used concurrently with radiation therapy and chemotherapy.
Sponsored by the University of California, San Francisco and Agenus, Inc. , the formal name of the study is Protocol C-100-37: PHASE 2, multi-center, single arm investigation of HSPPC-96 vaccine with temolozomide in patients with newly diagnosed GBM .
Key Eligibility Criteria:
Patients must be:
- At least 18 years old
- Not participating in any other clinical trial for malignant brain tumors
- Eligible for post-surgical treatment with radiotherapy and temozolomide.
Biological used: HSPPC-96
Patients will receive 4 weekly injections of HSPPC-96 followed by a 5th vaccine injection administered 2 weeks (+ 4 days) following vaccine administration #4 on the same day of the start of maintenance temozolomide (Day 36). Monthly vaccine injections will then begin on day 21 (+/- 7 days) of the first 28 day temozolomide cycle (Day 56 of the study) and will continue until depletion of vaccine or progression. Immune monitoring will be completed pre-operatively, intra-operatively, 48-hours post-surgery, prior to vaccine administration #1, at vaccine administration #5 and at weeks 09, 13, 37 and 53.The total volume of each vaccine or place provided is 0.47 mL. The total volume that should be administered is 0.4 mL (0.07 mL overage).