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

NCT ID: NCT01280552

Last Updated: 2017-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2015-12-31

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.

Conditions

Glioblastoma Multiforme

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ICT-107

Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens

Group Type: EXPERIMENTAL

ICT-107

Intervention Type: BIOLOGICAL

Autologous dendritic cells pulsed with immunogenic antigens

Control

Autologous dendritic cells that have not been pulsed with antigens

Group Type: PLACEBO_COMPARATOR

Placebo DC

Intervention Type: BIOLOGICAL

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

Interventions

ICT-107

Autologous dendritic cells pulsed with immunogenic antigens

Intervention Type: BIOLOGICAL

Placebo DC

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

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Precision Life Sciences Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony Gringeri, Ph.D.

Role: STUDY_DIRECTOR

Precision Life Sciences Group

Locations

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

Countries

United States

Other Identifiers

ICT-107-201

Identifier Type: -

Identifier Source: org_study_id