Malignant Brain Tumor Clinical Trials
Glioblastoma (GBM) tumors become enmeshed in brain tissue, making it nearly impossible to remove such brain tumors completely through surgery. The remnants quickly grow back, making GBM tumors one of the most difficult malignant brain tumors to treat.
The Westchester Brain Tumor Program is currently recruiting patients with newly diagnosed glioblastoma multiforme tumors for two different trials.
HSPPC-96 Vaccine
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.
Intervention Details:
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).
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DCVax®-L Vaccine
The patient-specific DCVax®-L vaccine is manufactured from a patient’s own white blood cells, which are exposed to cells from the patient’s tumor so they “learn” to recognize brain cancer cells. When re-injected under the patient’s skin, the vaccine’s white blood cells “teach” the immune system to recognize brain cancer cells. A one- or two-year supply of the vaccine is manufactured, and it is used in conjunction with radiation therapy and chemotherapy. In early trials, the vaccine has doubled the median survival time.
The study is officially called a Phase II Clinical Trial Evaluating DCVax®-L, Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen For The Treatment Of Glioblastoma Multiforme (GBM). Northwest Biotherapeutics is the trial sponsor.
Key Eligibility Criteria:
Patients must be:
- 18 to 70 years old
- Not participating in any other clinical trial for malignant brain tumors
- Eligible for post-surgical treatment with radiotherapy and temozolomide.
Details:
This Phase II trial is designed to evaluate the safety, clinical response and survival of patients following treatment with DCVax®-Brain, an immunotherapy treatment for GBM. The experimental therapy uses a patient's own tumor lysate and white blood cells from which precursors of the dendritic cells are isolated. T The dendritic cell is the starter engine of the immune system. The white cells are then made into dendritic cells and they are educated to "teach" the immune system how to recognize brain cancer cells.
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