Status:
COMPLETED
HSPPC-96 Vaccine With Temozolomide in Patients With Newly Diagnosed GBM
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Agenus Inc.
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 tum...
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 evalua...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 29 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 3 2014
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00905060
Start Date
June 29 2009
End Date
June 3 2014
Last Update
March 24 2021
Active Locations (9)
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1
University of California, San Francisco
San Francisco, California, United States, 94115
2
University of Miami
Miami, Florida, United States, 33136
3
Northwestern University
Chicago, Illinois, United States, 60611
4
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287