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

Alternate Title

Radiation Therapy Followed by Bleomycin in Treating Adult Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	Adult	NCI	RTOG-BR-0013 RTOG-DEV-1072, NCT00006916

Objectives

1. Determine the median survival time of patients with newly diagnosed supratentorial glioblastoma multiforme treated with radiotherapy followed by sustained release intratumoral bleomycin.
2. Determine the feasibility of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed supratentorial glioblastoma multiforme (with areas of necrosis) by surgical biopsy or excision within 4 weeks of study



• Tumor and/or any associated edema limited to one hemisphere and unifocal



• No gross invasion of a ventricular surface



• Tumor accessible



• No other astrocytoma



• No multifocal or recurrent malignant glioma



• No disease below the tentorium or beyond the cranial vault

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy for glioblastoma multiforme
• No prior radiosensitizer for glioblastoma multiforme

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy to the head or neck resulting in overlapping radiotherapy fields

Surgery:

• See Disease Characteristics
• Recovered from prior surgery

Patient Characteristics:

Age:

• Adult

Performance status:

• Zubrod 0-1

Life expectancy:

• At least 8 weeks

Hematopoietic:

• Hemoglobin at least 10 g/dL (transfusion allowed)
• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic:

• Bilirubin no greater than 2.0 mg/dL
• SGOT or SGPT no greater than 2 times normal

Renal:

• BUN no greater than 25 mg/dL
• Creatinine no greater than 1.5 mg/dL

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No hypersensitive or idiosyncratic reaction to bleomycin
• No other prior malignancies within the past 2 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix or urinary bladder
• No other major medical illness or psychiatric impairment that would preclude study participation

Expected Enrollment

A total of 72 patients will be accrued for this study within 5 months.

Outline

This is a multicenter study.

Within 4 weeks after surgical resection, patients receive radiotherapy daily 5 days a week for 6 weeks.

Within 2-6 weeks after completion of radiotherapy or at disease progression during radiotherapy, patients undergo surgical implantation of a modified Ommaya reservoir within the central area of the tumor. Patients then receive sustained release bleomycin intratumorally via the reservoir once a week for up to 2 years in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Roy Patchell, MD, Protocol chair		Ph: 859-323-5672

Registry Information
Official Title		A Phase II Trial Of Conventional Radiation Therapy Followed By Intratumoral Bleomycin Delivered Using A Refillable, Sustained Release Device (IND# 46,592) For The Treatment Of Supratentorial Glioblastoma
Trial Start Date		2001-06-06
Trial Completion Date		2006-05-08
Registered in ClinicalTrials.gov		NCT00006916
Date Submitted to PDQ		2000-10-26
Information Last Verified		2003-09-30
NCI Grant/Contract Number		CA21661