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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01280552
Recruitment Status : Completed
First Posted : January 20, 2011
Results First Posted : October 7, 2014
Last Update Posted : March 20, 2017
Sponsor:
Information provided by (Responsible Party):
Precision Life Sciences Group

Study Description
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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.

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Biological: ICT-107 Biological: Placebo DC Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : January 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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: Control
Autologous dendritic cells that have not been pulsed with antigens
 Biological: Placebo DC
Autologous dendritic cells (DC) that have not been pulsed with antigens


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 2 -3 years ]
    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. Overall Survival in HLA-A2 Patients [ Time Frame: 2-3 years ]
    Overall survival in a predefined subpopulation. All randomized patients are included in intent to treat analysis.


Secondary Outcome Measures :
  1. PFS [ Time Frame: 2-3 years ]

    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.

  2. Progression Free Survival in HLA- A2 Patients [ Time Frame: 2-3 yers ]

    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



Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01280552


Locations
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Sponsors and Collaborators
Precision Life Sciences Group
Investigators
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Study Director: Anthony Gringeri, Ph.D. Precision Life Sciences Group
More Information
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Responsible Party: Precision Life Sciences Group
ClinicalTrials.gov Identifier: NCT01280552    
Other Study ID Numbers: ICT-107-201
First Posted: January 20, 2011    Key Record Dates
Results First Posted: October 7, 2014
Last Update Posted: March 20, 2017
Last Verified: February 2017
Keywords provided by Precision Life Sciences Group:
Glioblastoma Multiforme
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue