Clinical Trial Alliance A071101
- A Phase II Randomized Trial Comparing the Efficacy of Heat Shock Protein-Peptide Complex-96 (HSPPC-96)(NSC #725085, Alliance IND#15380) Vaccine Given with Bevacizumab Versus Bevacizumab Alone in the Treatment of Surgically Resectable Recurrent Glioblastoma Multiforme (GBM)
- Principal Investigator
- Jeffrey Raizer
- Status: Accepting New Patients
- Study Type: Therapeutic, Treatment
- Protocol No:.Alliance A071101
- The purpose of this study is to compare what effects, good and/or bad, a vaccine called HSPPC-96 given with a drug called bevacizumab versus bevacizumab alone has on recurrent glioblastoma multiforme (GBM).
- HSPPC-96 is experimental (not approved by the U.S. Food and Drug Administration [FDA]). HSPPC-96 is a protein made from the tissue of the GBM and then given back in the form of a vaccine. Earlier studies showed significant immune response (improvement in the body's ability to fight disease) and it is hoped that this will target an attack against the remaining brain tumor cells. Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels and is used as treatment recurrent (cancer that has come back) glioblastoma. The use of HSPPC-96 in combination with bevacizumab is investigational.
Some of the eligibility criteria include:
- Participants must be 18 years of age or older.
- Participants must have diagnosis of recurrent GBM (it has returned after prior treatment).
- Participants GBM must be considered surgically resectable (able to be removed by surgery).
- Participants must not have had prior treatment with any anti-angiogenic agent (drug) targeting the vascular endothelial growth factor (VEGF), for example bevacizumab. Contact the study doctor for questions regarding these drugs.
- Description of Treatment
- Participants will be randomized (like the flip of a coin) into one of three groups known as Arms. Arm 1 participants will receive the HSPPC-96 vaccine about 4 weeks after surgery. The vaccine is given as an injection into the skin (a shot). Participants will get the vaccine once a week for 4 weeks (4 shots), then every other week for 6-12 more doses. During this same time, participants will get bevacizumab every 2 weeks. Bevacizumab is given intravenously (through a vein in the arm; IV). In Arm 2, about 4 weeks after surgery, participants will receive the HSPPC-96 vaccine alone. They will then get bevacizumab if the tumor comes back. In Arm 3, about 4 weeks after surgery, participants will receive bevacizumab alone. Participants will continue to get HSPCC-96 and/or bevacizumab until the tumor comes back or the study doctor decides it is in their best interest to stop.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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- A Phase I Study of Ad-RTS-hIL-12, an Inducible Adenoviral Vector Engineered to Express hIL-12 in the Presence of the Activator Ligand Veledimex in Subjects with Recurrent or Progressive Glioblastoma or Grade III Malignant Glioma
- A Phase 2, Multicenter, Open-Label Study Of BGJ398 in Patients with Recurrent Resectable or Unresectable Glioblastoma
- An Open Label Phase 1b/2 Study of Orally Administered PLX3397 in Combination with Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma
- A Phase 1/2 Study of SL-701, a Subcutaneously Injected Multivalent Glioma-Associated Antigen Vaccine, in Adult Patients with Recurrent Glioblastoma Multiforme
- Phase I/II Dose Escalation Trial to Assess Safety of Intrathecal Trastuzumab for the Treatment of Leptomeningeal Metastases in HER2 Positive Cancer
- A Phase II Study of the Efficacy of Hypofractionated Radiation Therapy with Bevacizumab and Temozolomide Followed by Maintenance Temozolomide and Bevacizumab for Recurrent High-Grade Gliomas
- A Phase I-II trial Everolimus and Sorafenib in Patients with Recurrent High-Grade Gliomas BTTC09-01
- A Phase II Trial of Oral Pazopanib plus Oral Topotecan Metronomic Antiangiogenic Therapy for Recurrent Glioblastoma Multiforme (A) without Prior Bevacizumab Exposure and (B) after Failing Prior Bevacizumab
- Phase II Randomized Study of Rituximab, Methotrexate, Procarbazine, Vincristine & Cytarabine with and without Low-Dose Whole-Brain Radiotherapy for Primary Central Nervous System Lymphoma
- Randomized Phase II of Concurrent Bevacizumab & Re-Irradiation Versus Bevacizumab Alone as Treatment for Recurrent Glioblastoma
last updated: 06-Oct-15 05:31 PM
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