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Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

NCT00643097 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-02-01

Study results available
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Summary

RATIONALE: Vaccines made from a peptide may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as GM-CSF, increase the number of white blood cells and platelets found in bone marrow or peripheral blood. Giving vaccine therapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with newly diagnosed glioblastoma multiforme.

Conditions

  • Malignant Neoplasms of Brain

Interventions

BIOLOGICAL

PEP-3 vaccine

Given intradermally

BIOLOGICAL

sargramostim

Given intradermally

DRUG

Temozolomide

Standard of care chemotherapy

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • John Sampson

    lead OTHER

Principal Investigators

  • Gordana Vlahovic, MD · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2012-01-31
Completion
2016-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00643097 on ClinicalTrials.gov