Title 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

IRB ICT 1310

CC CC00118

Hospital Main Campus

Stage N/A

Phase Phase 2

Disease Brain

Drug ICT-107



  1. To determine the safety and tolerability of ICT-107
  2. To describe the immune response in patients treated with ICT-107
  3. To determine predictors of response
Inclusion Criteria

Inclusion Criteria

  1. Confirmed, initial diagnosis of GBM
  2. ≥ 18 years of age
  3. Human leukocyte antigen- (HLA-) A1 or HLA-A2 positive
  4. Karnofsky Performance Score (KPS) of ≥ 70%
  5. 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
  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. Written informed consent, Release of Medical Records Form and HIPAA reviewed and signed by patient or legally authorized representatives.
Exclusion Criteria

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, cervical carcinoma in situ, early stage prostate carcinoma not requiring active treatment
  4. Severe pulmonary, cardiac or other systemic disease
  5. Congestive heart failure Class III or IV according to New York Heart Association
  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 positivity or acquired immunodeficiency syndrome related illness or other serious medical condition
  9. Breastfeeding
  10. Received any other therapeutic investigational agent within 30 days of enrollment
  11. 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
  12. Contraindication to MRI