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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00905060
First Posted: May 20, 2009
Last Update Posted: November 14, 2014
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.
Collaborator:
Agenus Inc.
Information provided by (Responsible Party):
Jennifer Clarke, University of California, San Francisco
May 18, 2009
May 20, 2009
November 14, 2014
June 2009
April 2014   (Final data collection date for primary outcome measure)
  • 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 safety profile of HSPPC-96 with concurrent temozolomide in patients with newly diagnosed GBM.
Complete list of historical versions of study NCT00905060 on ClinicalTrials.gov Archive Site
  • To evaluate the immunologic response to vaccine treatment [ Time Frame: survival ]
  • Progression Free Survival from date of surgical resection [ Time Frame: survival ]
To evaluate the immunologic response to vaccine treatment
Not Provided
Not Provided
 
HSPPC-96 Vaccine With Temozolomide in Patients With Newly Diagnosed GBM
PHASE 2, Multi-center, Single Arm Investigation of HSPPC-96 Vaccine With Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme
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.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
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
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.
Intervention: Biological: HSPPC-96
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
April 2014
April 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00905060
081010
C-100-37 ( Other Identifier: Agenus )
Yes
Not Provided
Not Provided
Jennifer Clarke, University of California, San Francisco
University of California, San Francisco
Agenus Inc.
Principal Investigator: Jennifer Clarke, MD UCSF Department of Neurosurgery
University of California, San Francisco
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP