A Study of ICT-107 Immunotherapy in Glioblastoma Multiforme (GBM)

Completed · Phase 2 · Has a placebo group

Conditions studied: Glioblastoma Multiforme

In brief

This is a phase 2, multicenter study to determine the safety and efficacy of ICT-107 in treating a type of brain tumor called Glioblastoma Multiforme (GBM). ICT-107 is an immunotherapy in which the patient's immune response will be stimulated to kill the tumor cells. Patients must be newly diagnosed with GBM and not yet received chemoradiation. Some of the patient's white blood cells (WBC) will be removed and cultured in a laboratory with purified antigens, similar to those on GBM cells. The patient's own WBC/DC that have been exposed to the tumor antigens will then be given back to the patient as a vaccine over several months. The goal is for the ICT-107 vaccine to stimulate the patient's immune response to kill the remaining GBM tumor cells after surgery and chemotherapy.

Key facts

Study ID

NCT01280552

Run by

Precision Life Sciences Group

People needed

124

Starts

2011-01-01

Expected to finish

2015-12-01

Last updated by the study team

2017-03-20

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed, initial diagnosis of GBM. Patients must be newly diagnosed with GBM and not yet received chemoradiation.
• ≥ 18 years of age
• HLA-A1 or HLA-A2 positive
• KPS score of ≥ 70%
• 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
• 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)
• Sufficient paraffin embedded tumor sample for analysis MGMT methylation status
• 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

You may not qualify if…

• 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)
• Severe pulmonary, cardiac or other systemic disease
• Congestive heart failure Class III or IV according to New York Heart Association (NYHA)
• 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 (HIV) positivity or acquired immunodeficiency syndrome (AIDS) related illness or other serious medical illness
• Breastfeeding
• Received any other therapeutic investigational agent within 30 days of enrollment
• Reduction of steroids (dexamethasone) to a maximum of 2 mg twice a day (BID) prior to the first administration of study vaccine

Where it is running

• University of Alabama at Birbingham School of Medicine — South Birmingham, Alabama, United States
• Arizona Cancer Center — Tucson, Arizona, United States
• UC San Diego Moores Cancer Center — La Jolla, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Jewish Hospital Medical Center — Louisville, Kentucky, United States
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• Massachusetss General Hospital — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• New Jersey Neuroscience Institute — Edison, New Jersey, United States
• Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• The Long Island Brain Tumor Center at Neurological Surgery, PC — Great Neck, New York, United States
• NYU Clinical Cancer Center — New York, New York, United States
• Weil Cornell Medical College — New York, New York, United States
• Wake Forest University — Winston-Salem, North Carolina, United States
• Case Comprehensive Cancer Center — Cleveland, Ohio, United States
• Cleveland Clinic Rose Ella Burkhardt Brain Tumor and Neuro Oncology Center — Cleveland, Ohio, United States
• Penn State Hershey Medical Center — Hershey, Pennsylvania, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Sammons Cancer Center (Baylor) — Dallas, Texas, United States
• University of Texas Health Science Center at Houston — Houston, Texas, United States
• University of Virginia Health System — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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