Back to resultsA Study of ICT-107 Immunotherapy in Glioblastoma Multiforme (GBM)
Primary Purpose
Glioblastoma Multiforme
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ICT-107
Placebo DC
Sponsored by
About this trial
This is an interventional treatment trial for Glioblastoma Multiforme focused on measuring Glioblastoma Multiforme
Eligibility Criteria
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
Sites / Locations
- University of Alabama at Birbingham School of Medicine
- Arizona Cancer Center
- UC San Diego Moores Cancer Center
- Cedars-Sinai Medical Center
- H. Lee Moffitt Cancer Center and Research Institute
- Northwestern Memorial Hospital
- Rush University Medical Center
- Jewish Hospital Medical Center
- Johns Hopkins University School of Medicine
- Massachusetss General Hospital
- Massachusetts General Hospital
- New Jersey Neuroscience Institute
- Cancer Institute of New Jersey
- The Long Island Brain Tumor Center at Neurological Surgery, PC
- NYU Clinical Cancer Center
- Weil Cornell Medical College
- Wake Forest University
- Case Comprehensive Cancer Center
- Cleveland Clinic Rose Ella Burkhardt Brain Tumor and Neuro Oncology Center
- Penn State Hershey Medical Center
- University of Pennsylvania
- Thomas Jefferson University
- Sammons Cancer Center (Baylor)
- University of Texas Health Science Center at Houston
- University of Virginia Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ICT-107
Control
Arm Description
Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens
Autologous dendritic cells that have not been pulsed with antigens
Outcomes
Primary Outcome Measures
Overall Survival (OS)
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
Overall Survival in HLA-A2 Patients
Overall survival in a predefined subpopulation. All randomized patients are included in intent to treat analysis.
Secondary Outcome Measures
PFS
Secondary Endpoints
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.
Population is all randomized patients ITT.
Progression Free Survival in HLA- A2 Patients
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
Full Information
NCT ID
NCT01280552
First Posted
January 19, 2011
Last Updated
February 10, 2017
Sponsor
Precision Life Sciences Group
1. Study Identification
Unique Protocol Identification Number
NCT01280552
Brief Title
A Study of ICT-107 Immunotherapy in Glioblastoma Multiforme (GBM)
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Precision Life Sciences Group
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
The proposed phase 2 study is a randomized, double blind, controlled study of the safety and efficacy of ICT-107 in newly diagnosed patients with glioblastoma multiforme (GBM) following resection and chemoradiation. The phase 1 clinical trial demonstrated safety and promising efficacy in a small, open-label study. The purpose of this study is to provide information from a larger, controlled clinical trial. Patients must be newly diagnosed with GBM and not yet received chemoradiation. Patients will have had tumor resection, magnetic resonance imaging (MRI) and tumor assessment prior to enrollment into the study. Post surgical treatment consists of 6 weeks of chemotherapy (TMZ) and radiation followed by a washout period. After Screening and informed consent, patients will undergo apheresis at the study site for collection of peripheral blood mononuclear cells (PBMCs). Apheresis product will be sent to a central site where monocytes will be purified and cultured into dendritic cells (DC). DC will be pulsed with synthetic peptides that correspond to immunogenic epitopes of tumor antigens. The pulsed dendritic cells will then be aliquoted and frozen before shipping back to the site. Patients will have the autologous DCs reinfused intradermally. A control group will receive unpulsed autologous DC. Patients will be randomized by age in a 2:1 ratio to ICT-107 or control.Patients will receive at least four intradermal injections of the ICT-107 vaccine and additional vaccine during a maintenance phase. The primary objective is to compare overall survival (OS) and progression free survival (PFS) in patients when treated with ICT-107 versus Control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma Multiforme
Keywords
Glioblastoma Multiforme
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ICT-107
Arm Type
Experimental
Arm Description
Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Autologous dendritic cells that have not been pulsed with antigens
Intervention Type
Biological
Intervention Name(s)
ICT-107
Intervention Description
Autologous dendritic cells pulsed with immunogenic antigens
Intervention Type
Biological
Intervention Name(s)
Placebo DC
Intervention Description
Autologous dendritic cells (DC) that have not been pulsed with antigens
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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
Time Frame
2 -3 years
Title
Overall Survival in HLA-A2 Patients
Description
Overall survival in a predefined subpopulation. All randomized patients are included in intent to treat analysis.
Time Frame
2-3 years
Secondary Outcome Measure Information:
Title
PFS
Description
Secondary Endpoints
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.
Population is all randomized patients ITT.
Time Frame
2-3 years
Title
Progression Free Survival in HLA- A2 Patients
Description
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
Time Frame
2-3 yers
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Gringeri, Ph.D.
Organizational Affiliation
Precision Life Sciences Group
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birbingham School of Medicine
City
South Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Jewish Hospital Medical Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40245
Country
United States
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetss General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
New Jersey Neuroscience Institute
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08818
Country
United States
Facility Name
Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
The Long Island Brain Tumor Center at Neurological Surgery, PC
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
NYU Clinical Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Weil Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Wake Forest University
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic Rose Ella Burkhardt Brain Tumor and Neuro Oncology Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Sammons Cancer Center (Baylor)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of ICT-107 Immunotherapy in Glioblastoma Multiforme (GBM)
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