An Immunotherapy Vaccine Against Grade IV Brain Tumors

This study has been suspended.

First Received: August 27, 2004 Last Updated: January 27, 2006 History of Changes

Sponsors and Collaborators:	M.D. Anderson Cancer Center Goodwin Foundation
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00090597

Purpose

The goal of this clinical research study is to learn if a special peptide (protein) vaccine (PEP-3-KLH) can help to activate your immune system and help your body fight off tumor cells in the brain.

Condition	Intervention	Phase
Brain Neoplasms	Biological: PEP-3-KLH	Phase II

MedlinePlus related topics: Brain Cancer Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment
Official Title:	A Complementary Trial of an Immunotherapy Vaccine Against Tumor-Specific EGFRvIII

Further study details as provided by M.D. Anderson Cancer Center:

Estimated Enrollment:	22
Study Start Date:	April 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Newly diagnosed, previously untreated GBM
Karnofsky Performance Status (KPS) >80
Histopathology diagnosis of GBM
Tumor resection of 95% or greater
Whole Brain Radiation completed
MRI within 30 days showing no disease progression
Tumor EGFRvIII positive

Exclusion Criteria:

Pregnant or breast-feeding
Receiving corticosteroids > 2mg/day
Leptomeningeal disease
Active infection requiring treatment
Unstable or severe intercurrent medical condition
Any autoimmune disease
Known immunosuppressive disease
Positive hepatitis B Serologies

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090597

Locations

United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Goodwin Foundation

More Information

No publications provided

Study ID Numbers:	2003-0343
Study First Received:	August 27, 2004
Last Updated:	January 27, 2006
ClinicalTrials.gov Identifier:	NCT00090597 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Newly diagnosed Glioblastoma Brain Tumors

Study placed in the following topic categories:

Brain Neoplasms
Glioblastoma
Central Nervous System Diseases

Central Nervous System Neoplasms
Brain Diseases
Nervous System Neoplasms

Additional relevant MeSH terms:

Brain Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases

Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Nervous System Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009