Surgery Followed by Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

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. Identifier: NCT00053183
Recruitment Status : Completed
First Posted : January 28, 2003
Last Update Posted : February 9, 2009
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. External-beam radiation therapy uses high-energy x-rays to kill tumor cells. Combining internal radiation with external-beam radiation therapy may kill any remaining tumor cells following surgery.

PURPOSE: Phase I trial to study the effectiveness of combining internal radiation therapy with external-beam radiation therapy in treating patients who have undergone surgery for glioblastoma multiforme.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Procedure: conventional surgery Radiation: brachytherapy Radiation: radiation therapy Phase 1

Detailed Description:


  • Determine the maximum tolerated dose of brachytherapy administered via GliaSite RTS™ applicator followed by external beam radiotherapy in patients with newly diagnosed glioblastoma multiforme.
  • Determine the acute and chronic toxicity of brachytherapy administered via GliaSite RTS™ in these patients.
  • Determine the survival rate of patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of brachytherapy.

Patients undergo craniotomy for histologic confirmation of glioblastoma multiforme, surgical resection, and placement of a GliaSite RTS™ applicator that includes Iotrex™.

Beginning 3-21 days after surgery, patients undergo brachytherapy via the GliaSite RTS™ applicator. Within 30 days of brachytherapy (no more than 60 days after resection) patients undergo external beam radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 5-10 patients receive escalating doses of brachytherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 5 or 3 of 10 patients experience dose-limiting toxicity.

Patients are followed at 21-35 days, every 2 months for 1 year, and then for survival.

PROJECTED ACCRUAL: A total of 15-100 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase I Brachytherapy Dose Escalation Using The GliaSite RTS In Newly Diagnosed Glioblastoma Multiforme In Conjunction With External Beam Radiation Therapy
Study Start Date : October 2003

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Clinically suspected supratentorial grade IV glioblastoma multiforme
  • Candidate for maximal surgical resection of tumor mass

    • Expected residual enhancing tumor must be within the expected brachytherapy treatment volume
    • Resection must not be expected to result in a new permanent neurologic deficit
  • No clearly multi-focal disease (2 or more separate foci of contrast-enhancing tumor not all within the expected brachytherapy prescription volume by MRI)
  • No enhancing tumor greater than 1 cm beyond the midline by MRI
  • No grossly or radiographically apparent leptomeningeal spread and/or ventricular invasion outside the anticipated radiation treatment volume
  • No marked edema by MRI with significant shift that is not anticipated to be corrected by resection



  • 18 and over

Performance status

  • Karnofsky 60-100%

Life expectancy

  • Not specified


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Not specified


  • Creatinine no greater than 1.7 mg/dL
  • BUN no greater than 2 times upper limit of normal


  • No uncontrolled hypertension
  • No unstable angina pectoris
  • No uncontrolled cardiac dysrhythmia


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Mini mental state exam score at least 15
  • No other concurrent medical illness that would preclude study participation
  • No concurrent serious infection
  • No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer


Biologic therapy

  • No immunotherapy prior to, during, or within 90 days after brachytherapy
  • No biologic therapy with any of the following prior to, during, or within 90 days after brachytherapy :

    • Immunotoxins
    • Immunoconjugates
    • Antiangiogenesis compounds
    • Peptide receptor antagonists
    • Interferons
    • Interleukins
    • Tumor-infiltrating lymphocytes
    • Lymphokine-activated killer cells
    • Gene therapy
    • Antisense agents


  • No chemotherapy or polifeprosan 20 with carmustine implant (Gliadel wafers) prior to, during, or within 90 days after brachytherapy

Endocrine therapy

  • No hormonal therapy prior to, during, or within 90 days after brachytherapy
  • Concurrent corticosteroids to improve quality of life allowed


  • No other radiotherapy prior to, during, or within 90 days after brachytherapy


  • See Disease Characteristics
  • No radiosurgery prior to, during, or within 90 days after brachytherapy


  • No other investigational agents directed at the brain tumor prior to, during, or within 90 days after brachytherapy
  • Concurrent noncytotoxic therapy to improve quality of life allowed

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 identifier (NCT number): NCT00053183

United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3295
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
United States, Georgia
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
United States, Michigan
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, North Carolina
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Abramson Cancer Center at University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-7811
Sponsors and Collaborators
National Cancer Institute (NCI)
Study Chair: Volker W. Stieber, MD Wake Forest University Health Sciences Identifier: NCT00053183     History of Changes
Other Study ID Numbers: CDR0000269300
First Posted: January 28, 2003    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: July 2004

Keywords provided by National Cancer Institute (NCI):
adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases