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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
Download the Cleveland Clinic Cancer Clinical Trials App
Stay up to date on Cleveland Clinic’s more than 200 active clinical trials for cancer patients. Our free Cancer Clinical Trials app is available for Apple and Android devices.
With this app, you can:
- Search our real time database for trials by disease, phase, physician or hospital location
- Browse information on each trial’s objective, eligibility criteria, stage(s) and more
- Connect to our Cancer Answer Line for more information about a trial or to enroll patients
The app also includes contacts for patient resources, financial services information, support groups and treatment guides.
Cancer Answers & Appointments
Speak with a cancer nurse specialist for appointment assistance and for answers to your questions about cancer locally at 216.444.7923 or toll-free 1.866.223.8100.
Monday through Friday from 8 a.m. – 4:30 p.m. (ET).
Resources for medical professionals
- Outpatient appointment referrals: 216.444.7923 or 866.223.8100
- Inpatient hospital transfers: 800.553.5056
- Referring Physician Concierge: 216.444.6196 or 216.312.4910.
Search available cancer clinical trials by disease, hospital, phase or number.
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Please consult your health care provider for advice about a specific medical condition.
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