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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Confirmed, initial diagnosis of GBM. Patients must be newly diagnosed with GBM and not yet received chemoradiation. 2. ≥ 18 years of age. 3. HLA-A1 or HLA-A2 positive. 4. KPS score of ≥ 70% 5. 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. 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. Sufficient paraffin embedded tumor sample for analysis MGMT methylation status. 9. 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:

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) 4. Severe pulmonary, cardiac or other systemic disease. 5. Congestive heart failure Class III or IV according to New York Heart Association (NYHA) 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 (HIV) positivity or acquired immunodeficiency syndrome (AIDS) related illness or other serious medical illness. 9. Breastfeeding. 10. Received any other therapeutic investigational agent within 30 days of enrollment. 11. Reduction of steroids (dexamethasone) to a maximum of 2 mg twice a day (BID) prior to the first administration of study vaccine

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01280552
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Precision Life Sciences Group
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Anthony Gringeri, Ph.D.
Principal Investigator Affiliation Precision Life Sciences Group
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma Multiforme
Additional Details

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.

Arms & Interventions

Arms

Experimental: ICT-107

Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens

Placebo Comparator: Control

Autologous dendritic cells that have not been pulsed with antigens

Interventions

Biological: - ICT-107

Autologous dendritic cells pulsed with immunogenic antigens

Biological: - Placebo DC

Autologous dendritic cells (DC) that have not been pulsed with antigens

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

South Birmingham, Alabama

Status

Address

University of Alabama at Birbingham School of Medicine

South Birmingham, Alabama, 35294

Arizona Cancer Center, Tucson, Arizona

Status

Address

Arizona Cancer Center

Tucson, Arizona, 85724

UC San Diego Moores Cancer Center, La Jolla, California

Status

Address

UC San Diego Moores Cancer Center

La Jolla, California, 92093

Cedars-Sinai Medical Center, Los Angeles, California

Status

Address

Cedars-Sinai Medical Center

Los Angeles, California, 90048

Tampa, Florida

Status

Address

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612

Northwestern Memorial Hospital, Chicago, Illinois

Status

Address

Northwestern Memorial Hospital

Chicago, Illinois, 60611

Rush University Medical Center, Chicago, Illinois

Status

Address

Rush University Medical Center

Chicago, Illinois, 60612

Jewish Hospital Medical Center, Louisville, Kentucky

Status

Address

Jewish Hospital Medical Center

Louisville, Kentucky, 40245

Baltimore, Maryland

Status

Address

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287

Massachusetss General Hospital, Boston, Massachusetts

Status

Address

Massachusetss General Hospital

Boston, Massachusetts, 02114

Massachusetts General Hospital, Boston, Massachusetts

Status

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

New Jersey Neuroscience Institute, Edison, New Jersey

Status

Address

New Jersey Neuroscience Institute

Edison, New Jersey, 08818

Cancer Institute of New Jersey, New Brunswick, New Jersey

Status

Address

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901

Great Neck, New York

Status

Address

The Long Island Brain Tumor Center at Neurological Surgery, PC

Great Neck, New York, 11021

NYU Clinical Cancer Center, New York, New York

Status

Address

NYU Clinical Cancer Center

New York, New York, 10016

Weil Cornell Medical College, New York, New York

Status

Address

Weil Cornell Medical College

New York, New York, 10065

Wake Forest University, Winston Salem, North Carolina

Status

Address

Wake Forest University

Winston Salem, North Carolina, 27157

Case Comprehensive Cancer Center, Cleveland, Ohio

Status

Address

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106

Cleveland, Ohio

Status

Address

Cleveland Clinic Rose Ella Burkhardt Brain Tumor and Neuro Oncology Center

Cleveland, Ohio, 44195

Penn State Hershey Medical Center, Hershey, Pennsylvania

Status

Address

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033

University of Pennsylvania, Philadelphia, Pennsylvania

Status

Address

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Thomas Jefferson University, Philadelphia, Pennsylvania

Status

Address

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

Sammons Cancer Center (Baylor), Dallas, Texas

Status

Address

Sammons Cancer Center (Baylor)

Dallas, Texas, 75246

Houston, Texas

Status

Address

University of Texas Health Science Center at Houston

Houston, Texas, 77030

University of Virginia Health System, Charlottesville, Virginia

Status

Address

University of Virginia Health System

Charlottesville, Virginia, 22908