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

Study:

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

Rationale:

n/a

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.

Study Status: Active, not recruiting

Recruiting:
n/a

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

Verified by ImmunoCellular Therapeutics, Ltd. October, 2012

Sponsored by: ImmunoCellular Therapeutics, Ltd.
Information provided by: ImmunoCellular Therapeutics, Ltd.
ClinicalTrials.gov identifier: NCT01280552

Study Type: Interventional

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

Cleveland Clinic Rose Ella Burkhardt Brain Tumor and Neuro Oncology Center
Cleveland, Ohio 44195
United States

n/a

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
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