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

NCT01280552 | Completed Phase 2 Results DMC

• 1 other identifier: ICT-107-201
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 25

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.

Conditions

Glioblastoma Multiforme

Keywords

Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (2)

• 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

  2 -3 years

• Overall Survival in HLA-A2 Patients

  Overall survival in a predefined subpopulation. All randomized patients are included in intent to treat analysis.

  2-3 years

Secondary Outcomes (2)

• PFS

  2-3 years

• Progression Free Survival in HLA- A2 Patients

  2-3 yers

Study Arms (2)

ICT-107

EXPERIMENTAL

Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens

Biological: ICT-107

Control

PLACEBO COMPARATOR

Autologous dendritic cells that have not been pulsed with antigens

Biological: Placebo DC

Interventions

ICT-107 BIOLOGICAL

Autologous dendritic cells pulsed with immunogenic antigens

ICT-107

Placebo DC BIOLOGICAL

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

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Precision Life Sciences Group: lead

Study Sites (25)

University of Alabama at Birbingham School of Medicine

South Birmingham, Alabama, 35294, United States

Location

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Jewish Hospital Medical Center

Louisville, Kentucky, 40245, United States

Location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

Massachusetss General Hospital

Boston, Massachusetts, 02114, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

New Jersey Neuroscience Institute

Edison, New Jersey, 08818, United States

Location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

The Long Island Brain Tumor Center at Neurological Surgery, PC

Great Neck, New York, 11021, United States

Location

NYU Clinical Cancer Center

New York, New York, 10016, United States

Location

Weil Cornell Medical College

New York, New York, 10065, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Rose Ella Burkhardt Brain Tumor and Neuro Oncology Center

Cleveland, Ohio, 44195, United States

Location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Sammons Cancer Center (Baylor)

Dallas, Texas, 75246, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Results Point of Contact

• Title: Anthony Gringeri, Ph.D. Senior Vice President Strategic Resources
• Organization: ImmunoCellular Therapeutics Ltd.

anthony.gringeri@imuc.com

818 264 2300

Study Officials

• Anthony Gringeri, Ph.D.

  Precision Life Sciences Group

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2011
• First Posted: January 20, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2015
• Last Updated: March 20, 2017
• Results First Posted: October 7, 2014

Record last verified: 2017-02

Locations

US (25)