- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00905060
HSPPC-96 Vaccine With Temozolomide in Patients With Newly Diagnosed GBM (HeatShock)
PHASE 2, Multi-center, Single Arm Investigation of HSPPC-96 Vaccine With Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To evaluate the safety profile of HSPPC-96 (vitespen) administered concurrently with temozolomide in patients with newly diagnosed glioblastoma multiforme (GBM).
II. To evaluate survival in patients treated with an autologous tumor-derived heat shock protein peptide-complex (HSPPC-96) with concurrent temozolomide.
SECONDARY OBJECTIVES:
I. To evaluate progression-free survival (PFS) from date of surgical resection. II. To evaluate the immunologic response to vaccine treatment in a subset of evaluable patients.
OUTLINE:
Approximately 2-5 weeks after standard radiation therapy and temozolomide completion, patients receive vitespen intradermally (ID) on days 1, 8, 15, and 22. Beginning 2 weeks after the 4th dose of vitespen, patients receive a 5th dose of vitespen ID and maintenance temozolomide orally (PO) on days 1-5 (of 28 day courses). On day 21 of course 1, patients receive the 6th dose of vitespen ID and continue vaccinations monthly. Courses repeat every 28 days in the absence of vaccine depletion, disease progression, or unacceptable toxicity.
After completion of study treatment, patients are followed up every 12 weeks.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94115
- University of California, San Francisco
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Florida
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Miami, Florida, United States, 33136
- University of Miami
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Hospital
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New Jersey
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Paramus, New Jersey, United States, 07652
- The Valley Hospital
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New York
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Mount Kisco, New York, United States, 10549
- Northern Westchester Hospital
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New York, New York, United States, 10032
- Columbia University
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- University of Oklahoma
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Pre-surgery tissue acquisition Inclusion criteria
- Age > 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 principal investigator (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; absolute lymphocyte count (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 Response assessment in neuro-oncology criteria (RANO) criteria. Progression 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Protein Peptide-Complex (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.
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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.
Other Names:
Maintenance temozolomide treatment is given 2 weeks after administration of the fourth vaccine at an initial dose of 150 mg per square meter (mg/m2) for 5 consecutive days in a 28-day cycle.
The dose was increased to 200 mg/m2 for 5 days in subsequent cycles.
Other Names:
Patients will undergo standard surgical resection of intracranial tumor
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Treatment-Related Adverse Events of Any Grade
Time Frame: Up to 3 years
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Up to 3 years
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Median Overall Survival
Time Frame: Up to 3 years
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Overall survival is defined as the time from surgical resection to death of any cause.
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Up to 3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Median Progression Free Survival (PFS)
Time Frame: Up to 3 years
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PFS is defined as the duration of progression-free survival from the time from resection until either documented disease progression or death
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Up to 3 years
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Median PD-L1 Positivity in Circulating Myeloid Cells
Time Frame: Up to 53 Weeks
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Circulating myeloid cells (CD45+/CD11b+) obtained from patients at the time of surgery were analyzed for PD-L1 expression to determine the percent of myeloid cells positive for PD-L1 (cut off for positivity determined relative to Fluorescence Minus One (FMO) and isotype control).
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Up to 53 Weeks
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Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 081010
- C-100-37 (OTHER: Agenus)
- NCI-2015-01229 (REGISTRY: NCI Clinical Trials Reporting Program (CTRP))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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