A Randomized, Double-blind, Controlled Phase IIb Study of the Safety and Efficacy of ICT-107 in Newly Diagnosed Patients With Glioblastoma Multiforme (GBM) Following Resection and Chemoradiation

Fecha de inicio: 1 de enero de 2011

Inclusion Criteria: 1. Confirmed, initial diagnosis of GBM. Patients must be newly diagnosed with GBM and not yet received chemoradiation. 2. ≥ 18 years of age 3. HLA-A1 or HLA-A2 positive 4. KPS score of ≥ 70% 5. Baseline hematologic studies and chemistry profiles must meet the following criteria: Hemoglobin (Hgb) \> 9.9 g/dL total granulocyte count \> than 1000/mm3 platelet count \> 100,000/mm3 blood urea nitrogen (BUN) \< 30 mg/dL creatinine \< 2 mg/dL alkaline phosphatase (ALP), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 4x upper limit of normal (ULN) prothrombin time (PT) and activated partial thromboplastin time (PTT) ≤ 1.6x control unless therapeutically warranted 6. Female patients of child-bearing potential must have negative serum pregnancy test 7. If not surgically sterile, male and female patients of childbearing age must use double barrier contraception (hormonal; intrauterine device; barrier) 8. Sufficient paraffin embedded tumor sample for analysis MGMT methylation status 9. Written informed consent, Release of Medical Records Form and Health Insurance Portability and Accountability Act (HIPAA) reviewed and signed by patient or legally authorized representatives Exclusion Criteria: 1. Recurrent disease 2. Radiosurgery including Gamma Knife, linear accelerator based radiosurgery, CyberKnife and placement of Gliadel wafer 3. Presence of any other active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin) 4. Severe pulmonary, cardiac or other systemic disease 5. Congestive heart failure Class III or IV according to New York Heart Association (NYHA) 6. Presence of an acute infection requiring active treatment with antibiotics/antivirals; prophylactic administration is allowed 7. Known history of an autoimmune disorder 8. Known human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS) related illness or other serious medical illness 9. Breastfeeding 10. Received any other therapeutic investigational agent within 30 days of enrollment 11. Reduction of steroids (dexamethasone) to a maximum of 2 mg twice a day (BID) prior to the first administration of study vaccine