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

Brain and Central Nervous System Tumors Clinical Trial

Official title:

Phase I Brachytherapy Dose Escalation Using The GliaSite RTS In Newly Diagnosed Glioblastoma Multiforme In Conjunction With External Beam Radiation Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00053183
• Other study ID #: CDR0000269300
• Secondary ID: NABTT-2105JHOC-N
• Status: Completed
• Phase: Phase 1
• First received: January 27, 2003
• Last updated: February 6, 2009
• Start date: October 2003

Study information

• Verified date: July 2004
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Glioblastoma
• Nervous System Neoplasms

Intervention

Procedure:
• conventional surgery

Radiation:
• brachytherapy

• radiation therapy

Locations

Country	Name	City	State
United States	Winship Cancer Institute of Emory University	Atlanta	Georgia
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Josephine Ford Cancer Center at Henry Ford Hospital	Detroit	Michigan
United States	Abramson Cancer Center at University of Pennsylvania Medical Center	Philadelphia	Pennsylvania
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,