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Trial record 1 of 1 for:    C-100-37
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HSPPC-96 Vaccine With Temozolomide in Patients With Newly Diagnosed GBM (HeatShock)

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ClinicalTrials.gov Identifier: NCT00905060
Recruitment Status : Completed
First Posted : May 20, 2009
Results First Posted : March 24, 2021
Last Update Posted : March 24, 2021
Sponsor:
Collaborator:
Agenus Inc.
Information provided by (Responsible Party):
Orin Bloch, MD, University of California, San Francisco

Brief Summary:
This phase II trial studies the side effects and how well HSPPC-96 (vitespen) and temozolomide work in treating patients with newly diagnosed glioblastoma multiforme. Vaccines made from a person's tumor cells and heat shock protein peptide may help the body to build an effective immune response to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving HSPPC-96 (vitespen) together with temozolomide may kill more tumor cells.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Biological: HSPPC-96 Drug: Temozolomide Procedure: Standard Surgical Resection Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: N/A
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
Actual Study Start Date : June 29, 2009
Actual Primary Completion Date : June 3, 2014
Actual Study Completion Date : June 3, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Biological: 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.
Other Names:
  • Heat Shock
  • Vitespen

Drug: Temozolomide
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 Name: Temodar

Procedure: Standard Surgical Resection
Patients will undergo standard surgical resection of intracranial tumor
Other Name: Craniotomy




Primary Outcome Measures :
  1. Number of Participants With Treatment-Related Adverse Events of Any Grade [ Time Frame: Up to 3 years ]
  2. Median Overall Survival [ Time Frame: Up to 3 years ]
    Overall survival is defined as the time from surgical resection to death of any cause.


Secondary Outcome Measures :
  1. Median Progression Free Survival (PFS) [ Time Frame: Up to 3 years ]
    PFS is defined as the duration of progression-free survival from the time from resection until either documented disease progression or death

  2. Median PD-L1 Positivity in Circulating Myeloid Cells [ Time Frame: Up to 53 Weeks ]
    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).



Information from the National Library of Medicine

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

Inclusion Criteria:

Pre-surgery tissue acquisition Inclusion criteria

  1. Age > 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 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
  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; 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

  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 Response assessment in neuro-oncology criteria (RANO) criteria. Progression 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

Information from the National Library of Medicine

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


Locations
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United States, California
University of California, San Francisco
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
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Principal Investigator: Jennifer Clarke, MD University of California, San Francisco
Publications of Results:
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Responsible Party: Orin Bloch, MD, Principal Investigator, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00905060    
Obsolete Identifiers: NCT00912951
Other Study ID Numbers: 081010
C-100-37 ( Other Identifier: Agenus )
NCI-2015-01229 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) )
First Posted: May 20, 2009    Key Record Dates
Results First Posted: March 24, 2021
Last Update Posted: March 24, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Orin Bloch, MD, University of California, San Francisco:
Newly Diagnosed Glioblastoma Multiforme, vaccine
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents