A Phase 1 Trial of Peptide-Based Glioma Vaccine IMA950 in Patients With Glioblastoma (GBM)

Date de début de l'étude : 1 août 2011

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