HSPPC-96 Vaccine With Temozolomide in Patients With Newly Diagnosed GBM (HeatShock)

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Brain and Central Nervous System Tumors	Biological: HSPPC-96	Phase 2

Study Design

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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

Arms and Interventions

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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

Outcome Measures

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Primary Outcome Measures :

1. To evaluate the safety profile of HSPPC-96 administered concurrently temozolomide in patients with newly diagnosed GBM. [ Time Frame: survival ]
2. Survival Time [ Time Frame: survival ]

Secondary Outcome Measures :

1. To evaluate the immunologic response to vaccine treatment [ Time Frame: survival ]
2. Progression Free Survival from date of surgical resection [ Time Frame: survival ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Pre-surgery tissue acquisition Inclusion criteria

1. > or equal to 18 years old
2. Life expectancy of greater than 12 weeks.
3. Able to read and understand the informed consent document; must sign the informed consent
4. Must have suspected diagnosis of Glioblastoma Multiforme with a surgical intent to resect at least 90% of enhancing disease
5. Must be eligible for post-surgical treatment with radiotherapy and temozolomide

Post-radiation therapy/pre-vaccine eligibility Inclusion criteria

1. Agree to use contraception or abstain from sexual activity from the time of consent through 1 month after the end of study drug administration
2. Negative serum pregnancy test for female patients of childbearing potential
3. Patients with histologically proven, non-progressive glioblastoma multiforme (GBM)
4. Patient must have received standard of care radiation and temozolomide therapy
5. 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
6. All radiotherapy must be discontinued at least 2 weeks and no more than 5 weeks prior to the first planned vaccine administration
7. Availability of at least 4 doses of vaccine (at least 4 vials for clinical administration produced from the tumor provided)
8. Karnofsky functional status rating > or equal to 70
9. 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

1. Current diagnosis of Human Immunodeficiency Virus (HIV testing is not required per protocol)
2. 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
3. Any systemic autoimmune disease (e.g., Hashimoto's thyroiditis) and/or any history of primary or secondary immunodeficiency
4. Any prior therapy for glioma
5. Planned use or current use of other investigational therapy for the treatment of glioma

Post-radiation therapy/pre-vaccine Exclusion

1. Inability to comply with study-related procedures
2. 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
3. Current or active use of chemotherapy (except temozolomide) or immune therapy
4. 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
5. Patients with active uncontrolled infection
6. Evidence of bleeding diathesis
7. Unstable or severe intercurrent medical conditions
8. Female patients who are pregnant or breastfeeding

Contacts and Locations

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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

Sponsors and Collaborators

University of California, San Francisco

Agenus Inc.

Investigators

Principal Investigator:	Jennifer Clarke, MD	UCSF Department of Neurosurgery

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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