Trial record 1 of 1 for:    ict-107
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A Study of ICT-107 Immunotherapy in Glioblastoma Multiforme (GBM)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ImmunoCellular Therapeutics, Ltd.
ClinicalTrials.gov Identifier:
NCT01280552
First received: January 19, 2011
Last updated: October 17, 2012
Last verified: October 2012
  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.


Condition Intervention Phase
Glioblastoma Multiforme
Biological: ICT-107
Biological: Placebo DC
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by ImmunoCellular Therapeutics, Ltd.:

Primary Outcome Measures:
  • Overall survival (OS) [ Time Frame: 2 -3 years ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • PFS, immune response, safety [ Time Frame: 2-3 years ] [ Designated as safety issue: Yes ]

    Secondary Endpoints

    • To compare progression-free survival (PFS) in patients when treated with ICT 107 versus Control
    • To determine the safety and tolerability of ICT 107
    • To describe the immune response in patients treated with ICT 107
    • To determine predictors of response


Estimated Enrollment: 200
Study Start Date: January 2011
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ICT-107
Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens
Biological: ICT-107
Autologous dendritic cells pulsed with immunogenic antigens
Placebo Comparator: Placebo
Autologous dendritic cells that have not been pulsed with antigens
Biological: Placebo DC
Autologous dendritic cells (DC) that have not been pulsed with antigens

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01280552

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birbingham School of Medicine
South Birmingham, Alabama, United States, 35294
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, Kentucky
Jewish Hospital Medical Center
Louisville, Kentucky, United States, 40245
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Massachusetss General Hospital
Boston, Massachusetts, United States, 02114
United States, New Jersey
New Jersey Neuroscience Institute
Edison, New Jersey, United States, 08818
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
United States, New York
The Long Island Brain Tumor Center at Neurological Surgery, PC
Great Neck, New York, United States, 11021
NYU Clinical Cancer Center
New York, New York, United States, 10016
Weil Cornell Medical College
New York, New York, United States, 10065
United States, North Carolina
Wake Forest University
Winston Salem, North Carolina, United States, 27157
United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Cleveland Clinic Rose Ella Burkhardt Brain Tumor and Neuro Oncology Center
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Sammons Cancer Center (Baylor)
Dallas, Texas, United States, 75246
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
ImmunoCellular Therapeutics, Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: ImmunoCellular Therapeutics, Ltd.
ClinicalTrials.gov Identifier: NCT01280552     History of Changes
Other Study ID Numbers: ICT-107-201
Study First Received: January 19, 2011
Last Updated: October 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by ImmunoCellular Therapeutics, Ltd.:
Glioblastoma Multiforme

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on July 29, 2014