Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Completed 18 and over NCI NABTT-2105 JHOC-NABTT-2105, NCT00053183

Objectives

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

Entry Criteria

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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

New Approaches to Brain Tumor Therapy

Volker Stieber, MD, Protocol chair		Ph: 336-713-6560; 800-446-2255 Email: vstieber@wfubmc.edu

Registry Information
Official Title		Phase I Brachytherapy Dose Escalation Using The GliaSite RTS In Newly Diagnosed Glioblastoma Multiforme In Conjunction With External Beam Radiation Therapy
Trial Start Date		2003-10-22
Registered in ClinicalTrials.gov		NCT00053183
Date Submitted to PDQ		2002-11-18
Information Last Verified		2004-07-16
NCI Grant/Contract Number		CA062475

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