Peptide-based Glioma Vaccine IMA950 in Patients With Glioblastoma
| Status: | Completed |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/30/2013 |
| Start Date: | August 2011 |
| End Date: | March 2014 |
| Contact: | Joohee Sul, MD |
| Phone: | 301-402-6298 |
A Phase 1 Trial of Peptide-Based Glioma Vaccine IMA950 in Patients With Glioblastoma (GBM)
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 normal cells.
IMA950 is a therapeutic multi-peptide vaccine containing 11 tumor-associated peptides
(TUMAPs) found in a majority of glioblastomas, and is designed to activate TUMAP-specific T
cells. The use of 11 TUMAPs increases the likelihood of a multi-clonal, highly specific
T-cell response against tumor cells leading to decreased likelihood of immune evasion of the
tumor by down-regulation of target antigens.
PURPOSE: The primary objective of this study is to determine the safety and tolerability of
IMA950 when given with cyclophosphamide, granulocyte macrophage-colony stimulating factor
(GM-CSF) and imiquimod in patients with glioblastoma and to determine if IMA950 shows
sufficient immunogenicity in these patients.
ELIGIBILITY: Patients with histologically proven GBMs who have completed radiotherapy, and
have stable disease following at least 4 cycles of adjuvant temozolomide.
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
We found this trial at
1
site
Bethesda, Maryland 20892
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