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| Sponsor: | University of California, San Francisco |
|---|---|
| Collaborator: |
Agenus, Inc. |
| Information provided by (Responsible Party): | Andrew Parsa, University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00905060 |
Purpose
The Phase 2 trial is a single-arm investigation designed to evaluate safety, survival, and immune response in patients treated with an autologous tumor-derived heat shock protein peptide-complex (HSPPC-96) administered at 25 μg per dose injected intradermally once weekly for 4 consecutive weeks and monthly following standard treatment with radiation and temozolomide.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Biological: HSPPC-96 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | PHASE 2, Multi-center, Single Arm Investigation of HSPPC-96 Vaccine With Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme |
| Estimated Enrollment: | 55 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
Patients will receive 4 weekly injections of HSPPC-96 followed by a 5th vaccine injection on the same day of the start of maintenance temozolomide 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)3 weeks following vaccine administration #5 and will continue every 28 days 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 prior to 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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Pre-surgery tissue acquisition Inclusion criteria
Post-radiation therapy/pre-vaccine eligibility Inclusion criteria
Exclusion Criteria:
Pre-surgery tissue acquisition
Post-radiation therapy/pre-vaccine Exclusion
Contacts and Locations| United States, California | |
| UCSF Department of Neurosurgery | |
| San Francisco, California, United States, 94115 | |
| United States, Florida | |
| University of Miami | |
| Miami, Florida, United States, 33136 | |
| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| United States, Maryland | |
| Johns Hopkins Hospital | |
| Baltimore, Maryland, United States, 21287 | |
| United States, New Jersey | |
| The Valley Hospital | |
| Paramus, New Jersey, United States, 07652 | |
| United States, New York | |
| Northern Westchester Hospital | |
| Mount Kisco, New York, United States, 10549 | |
| Columbia University | |
| New York, New York, United States, 10032 | |
| United States, Oklahoma | |
| University of Oklahoma | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: | Andrew T Parsa, MD, PhD | UCSF Department of Neurosurgery |
More Information
| Responsible Party: | Andrew Parsa, Andrew T. Parsa, MD, PhD, UCSF Department of Neurosurgery, University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00905060 History of Changes |
| Obsolete Identifiers: | NCT00912951 |
| Other Study ID Numbers: | 081010, C-100-37 |
| Study First Received: | May 18, 2009 |
| Last Updated: | May 9, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Newly Diagnosed Glioblastoma Multiforme, vaccine |
|
Glioblastoma Nervous System Neoplasms Central Nervous System Neoplasms Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Temozolomide Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |