HSPPC-96 Vaccine With Temozolomide in Patients With Newly Diagnosed GBM (HeatShock)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00905060 |
Recruitment Status
:
Completed
First Posted
: May 20, 2009
Last Update Posted
: November 14, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Brain and Central Nervous System Tumors | Biological: HSPPC-96 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 46 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | June 2009 |
Actual Primary Completion Date : | April 2014 |
Actual Study Completion Date : | April 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: protein peptide-complex (HSPPC-96)
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.
|
Biological: HSPPC-96
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). Other Name: Heat Shock
|
- To evaluate the safety profile of HSPPC-96 administered concurrently temozolomide in patients with newly diagnosed GBM. [ Time Frame: survival ]
- Survival Time [ Time Frame: survival ]
- To evaluate the immunologic response to vaccine treatment [ Time Frame: survival ]
- Progression Free Survival from date of surgical resection [ Time Frame: survival ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Pre-surgery tissue acquisition Inclusion criteria
- > or equal to 18 years old
- Life expectancy of greater than 12 weeks.
- Able to read and understand the informed consent document; must sign the informed consent
- Must have suspected diagnosis of Glioblastoma Multiforme with a surgical intent to resect at least 90% of enhancing disease
- Must be eligible for post-surgical treatment with radiotherapy and temozolomide
Post-radiation therapy/pre-vaccine eligibility Inclusion criteria
- Agree to use contraception or abstain from sexual activity from the time of consent through 1 month after the end of study drug administration
- Negative serum pregnancy test for female patients of childbearing potential
- Patients with histologically proven, non-progressive glioblastoma multiforme (GBM)
- Patient must have received standard of care radiation and temozolomide therapy
- Must have undergone a at least a 90% resection (determined by the PI) measured by postoperative magnetic resonance imaging (MRI) scan, T1-weighted contrast scan, or CT scan if clinically indicated, performed within 72 hours after surgery
- All radiotherapy must be discontinued at least 2 weeks and no more than 5 weeks prior to the first planned vaccine administration
- Availability of at least 4 doses of vaccine (at least 4 vials for clinical administration produced from the tumor provided)
- Karnofsky functional status rating > or equal to 70
- Adequate bone marrow function including the absence of lymphopenia (ANC > 1,500/ mm3; ALC > 500/mm3 ; platelet count >100,000/mm3), adequate liver function (serum glutamic oxaloacetic transaminase/ aspartate aminotransferase [AST], alanine amino transferase [ALT], and alkaline phosphatase <2.5 times institutional upper limit of normals [IULNs] and bilirubin (total) <1.5 mg*IULN), and adequate renal function (BUN and creatinine <1.5 times IULNs
Exclusion Criteria:
Pre-surgery tissue acquisition
- Current diagnosis of Human Immunodeficiency Virus (HIV testing is not required per protocol)
- Any prior diagnosis of any other cancer or other concurrent malignancy, with the exception of adequately treated nonmetastatic in situ carcinoma of the uterine cervix or nonmetastatic nonmelanoma skin cancer unless in complete remission and off all therapy for that disease for a minimum of 5 years
- Any systemic autoimmune disease (e.g., Hashimoto's thyroiditis) and/or any history of primary or secondary immunodeficiency
- Any prior therapy for glioma
- Planned use or current use of other investigational therapy for the treatment of glioma
Post-radiation therapy/pre-vaccine Exclusion
- Inability to comply with study-related procedures
- Prior diagnosis of any other cancer or other concurrent malignancy, with the exception of adequately treated nonmetastatic in situ carcinoma of the uterine cervix or nonmetastatic nonmelanoma skin cancer unless in complete remission and off all therapy for that disease for a minimum of 5 years
- Current or active use of chemotherapy (except temozolomide) or immune therapy
- Contrast MRI findings (or CT scan if MRI is clinically contraindicated) consistent with progression per protocol defined modified RANO criteriaProgression prior to vaccination as determined by the Principal Investigator
- Patients with active uncontrolled infection
- Evidence of bleeding diathesis
- Unstable or severe intercurrent medical conditions
- Female patients who are pregnant or breastfeeding

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00905060
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: | Jennifer Clarke, MD | UCSF Department of Neurosurgery |
Responsible Party: | Jennifer Clarke, Principal Investigator, University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00905060 History of Changes |
Obsolete Identifiers: | NCT00912951 |
Other Study ID Numbers: |
081010 C-100-37 ( Other Identifier: Agenus ) |
First Posted: | May 20, 2009 Key Record Dates |
Last Update Posted: | November 14, 2014 |
Last Verified: | November 2014 |
Keywords provided by Jennifer Clarke, University of California, San Francisco:
Newly Diagnosed Glioblastoma Multiforme, vaccine |
Additional relevant MeSH terms:
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 Vaccines Temozolomide Dacarbazine Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |