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A Randomized, Double-blind, Controlled Phase II Study of the Safety and Efficacy of ICT-107 in Newly Diagnosed Patients with Glioblastoma Multiforme (Following Resection and Chemoradiation
- To determine the safety and tolerability of ICT-107
- To describe the immune response in patients treated with ICT-107
- To determine predictors of response
- Confirmed, initial diagnosis of GBM
- ≥ 18 years of age
- Human leukocyte antigen- (HLA-) A1 or HLA-A2 positive
- Karnofsky Performance Score (KPS) of ≥ 70%
- Baseline hematologic studies and chemistry profiles must meet the following criteria:
- hemoglobin (Hgb) > 9.9 g/dL
- absolute neutrophil count (ANC) > 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) ≤ 1.6 x control unless therapeutically warranted
- Female patients of child-bearing potential must have negative serum pregnancy test
- If not surgically sterile, male and female patients of childbearing age must use double barrier contraception (hormonal; intrauterine device; barrier)
- Written informed consent, Release of Medical Records Form and HIPAA reviewed and signed by patient or legally authorized representatives.
- Recurrent disease
- Radiosurgery including Gamma Knife, linear accelerator based radiosurgery, CyberKnife and placement of Gliadel wafer
- Presence of any other active malignancy or prior history of malignancy, except for: basal cell carcinoma of the skin, cervical carcinoma in situ, early stage prostate carcinoma not requiring active treatment
- Severe pulmonary, cardiac or other systemic disease
- Congestive heart failure Class III or IV according to New York Heart Association
- Presence of an acute infection requiring active treatment with antibiotics/antivirals; prophylactic administration is allowed
- Known history of an autoimmune disorder
- Known human immunodeficiency virus positivity or acquired immunodeficiency syndrome related illness or other serious medical condition
- Received any other therapeutic investigational agent within 30 days of enrollment
- Foreseeable condition which would preclude the reduction of steroids (dexamethasone) to a maximum of 2 mg twice a day (BID) within the seven days prior to first administration of study treatment
- Contraindication to MRI
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