Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00053183
First received: January 27, 2003
Last updated: February 6, 2009
Last verified: July 2004

January 27, 2003
February 6, 2009
October 2003
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00053183 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Surgery Followed by Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Phase I Brachytherapy Dose Escalation Using The GliaSite RTS In Newly Diagnosed Glioblastoma Multiforme In Conjunction With External Beam Radiation Therapy

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.

OBJECTIVES:

  • 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.

Interventional
Phase 1
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
  • Procedure: conventional surgery
  • Radiation: brachytherapy
  • Radiation: radiation therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
Not Provided

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 60-100%

Life expectancy

  • Not specified

Hematopoietic

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

Hepatic

  • Not specified

Renal

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

Cardiovascular

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

Other

  • 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

PRIOR CONCURRENT THERAPY:

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

Chemotherapy

  • 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

Radiotherapy

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

Surgery

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

Other

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00053183
CDR0000269300, NABTT-2105, JHOC-NABTT-2105
Not Provided
Not Provided
National Cancer Institute (NCI)
Not Provided
Study Chair: Volker W. Stieber, MD Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
July 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP