- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01280552
A Study of ICT-107 Immunotherapy in Glioblastoma Multiforme (GBM)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alabama
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South Birmingham, Alabama, United States, 35294
- University of Alabama at Birbingham School of Medicine
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Arizona
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Tucson, Arizona, United States, 85724
- Arizona Cancer Center
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California
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La Jolla, California, United States, 92093
- UC San Diego Moores Cancer Center
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Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
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Florida
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Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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Illinois
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Chicago, Illinois, United States, 60612
- Rush University Medical Center
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Chicago, Illinois, United States, 60611
- Northwestern Memorial Hospital
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Kentucky
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Louisville, Kentucky, United States, 40245
- Jewish Hospital Medical Center
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins University School of Medicine
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, United States, 02114
- Massachusetss General Hospital
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New Jersey
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Edison, New Jersey, United States, 08818
- New Jersey Neuroscience Institute
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New Brunswick, New Jersey, United States, 08901
- Cancer Institute of New Jersey
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New York
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Great Neck, New York, United States, 11021
- The Long Island Brain Tumor Center at Neurological Surgery, PC
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New York, New York, United States, 10016
- NYU Clinical Cancer Center
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New York, New York, United States, 10065
- Weil Cornell Medical College
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North Carolina
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Winston Salem, North Carolina, United States, 27157
- Wake Forest University
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Ohio
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Cleveland, Ohio, United States, 44106
- Case Comprehensive Cancer Center
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Rose Ella Burkhardt Brain Tumor and Neuro Oncology Center
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Penn State Hershey Medical Center
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University
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Texas
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Dallas, Texas, United States, 75246
- Sammons Cancer Center (Baylor)
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Houston, Texas, United States, 77030
- University of Texas Health Science Center at Houston
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Virginia
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Charlottesville, Virginia, United States, 22908
- University of Virginia Health System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ICT-107
Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens
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Autologous dendritic cells pulsed with immunogenic antigens
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Placebo Comparator: Control
Autologous dendritic cells that have not been pulsed with antigens
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Autologous dendritic cells (DC) that have not been pulsed with antigens
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival (OS)
Time Frame: 2 -3 years
|
The objective is to compare overall survival (OS) in patients when treated with ICT 107 versus Control.
OS defined as the time from randomization until date of death or the last date patient known alive (if death is not observed) All randomized patients are included in Intent to Treat analysis
|
2 -3 years
|
Overall Survival in HLA-A2 Patients
Time Frame: 2-3 years
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Overall survival in a predefined subpopulation.
All randomized patients are included in intent to treat analysis.
|
2-3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PFS
Time Frame: 2-3 years
|
Secondary Endpoints
|
2-3 years
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Progression Free Survival in HLA- A2 Patients
Time Frame: 2-3 yers
|
Progression Free Survival in a prespecified subpopulation of patients with HLA-A2 haplotype. Intent to treat population includes all randomized patients. PFS is defined as the time from randomization until the date of documented progressive disease (PD) or death, whichever occurs first, or last date known alive and progression free if progression or death is not observed |
2-3 yers
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICT-107-201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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