Status:
TERMINATED
Peptide-based Glioma Vaccine IMA950 in Patients With Glioblastoma
Lead Sponsor:
Immatics Biotechnologies GmbH
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
BACKGROUND: Active immunotherapy of cancer is based on the premise that the vaccine raises a cytotoxic immune response to tumor-associated antigens, thereby destroying malignant cells without harming ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically proven glioblastoma
- Stable disease following ≥ 4 cycles of adjuvant temozolomide
- No progression or recurrence of disease
- PATIENT CHARACTERISTICS:
- HLA-A\*02 positive
- ≥ 18 years old
- Life expectancy \> 8 weeks
- Karnofsky performance status ≥ 60
- WBC \>3,500/µL
- ALC \>350/mm3
- ANC \>1,500/mm3
- Platelet count \>100,000/mm3
- Hemoglobin \>10gm/dL
- AST, ALT and alkaline phosphatase \<2.5 times upper limit of normal (ULN)
- Bilirubin \<1.5 times ULN
- Creatinine \<1.5 mg/dL and/or creatinine clearance \>60cc/min
- Serum potassium, magnesium and calcium within normals levels (supplementation is allowed)
- Not pregnant or nursing
- Negative pregnancy test
- Practice birth control during and for 2 months after treatment with IMA950 (both genders)
- Women of childbearing age must agree to use adequate contraceptive methods
- No significant active hepatic, renal, infectious or psychiatric disease
- No HIV, active hepatitis infection, or any other active severe infectious disease
- No history of autoimmune disease or immunosuppression
- No clinically significant cardiovascular event within 3 months before study entry or an increased risk for ventricular arrhythmia
- No malignancy other than glioblastoma that required treatment during the last 12 months
- PRIOR and/or CONCURRENT THERAPY:
- See Disease Characteristics
- Completed radiotherapy and at least 4 cycles of adjuvant temozolomide
- Not be receiving steroids OR be on stable dose of steroids for ≥ 5 days prior to registration
- No other prior immunotherapy for glioblastoma
- No major surgery within 4 weeks prior to treatment start
- At least 4 weeks from cytotoxic therapies (incl. temozolomide)
- At least 2 weeks from non-cytotoxic therapies (e.g. interferon, tamoxifen)
- At least 3 weeks from bevacizumab
- No current treatment with imiquimod; prior use of imiquimod is allowed
Exclusion
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01403285
Start Date
August 1 2011
End Date
April 1 2014
Last Update
May 19 2014
Active Locations (1)
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1
Neuro-Oncology Branch of the National Cancer Institute, National Institutes of Health
Bethesda, Maryland, United States, 20892