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

NCT01280552 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2017-03-20

Study results available
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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

Interventions

BIOLOGICAL

ICT-107

Autologous dendritic cells pulsed with immunogenic antigens

BIOLOGICAL

Placebo DC

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

Sponsors & Collaborators

  • Precision Life Sciences Group

    lead INDUSTRY

Principal Investigators

  • Anthony Gringeri, Ph.D. · Precision Life Sciences Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01280552 on ClinicalTrials.gov