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

Brain and Central Nervous System Tumors Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00006916
• Other study ID #: RTOG-BR-0013
• Secondary ID: CDR0000068343
• Status: Terminated
• Phase: Phase 2
• Start date: June 2001
• Est. completion date: December 2005

Study information

• Verified date: November 2015
• Source: Radiation Therapy Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of radiation therapy followed by bleomycin in treating adult patients who have newly diagnosed supratentorial glioblastoma multiforme.

Description:

OBJECTIVES:

• Determine the median survival time of patients with newly diagnosed supratentorial glioblastoma multiforme treated with radiotherapy followed by sustained release intratumoral bleomycin.

• Determine the feasibility of this regimen in these patients.

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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 2.0 mg/dL

• Serum glutamic-oxaloacetic transaminase (SGOT) or Serum glutamic-pyruvic transaminase (SGPT) no greater than 2 times normal

Renal:

• Blood Urea Nitrogen (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

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

Related Conditions & MeSH terms

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

Intervention

Biological:
• bleomycin

Device:
• Ommaya reservoir

Radiation:
• radiation therapy
60.0 Gy/30 fractions x 2.0 Gy. For the first 46 Gy/23 fractions the treatment volume should include the volume of contrast-enhancing lesion and surrounding edema on pre-operative CT/MRI scan plus a 2 centimeter margin. If no edema is present, the margin should be 2.5 cm. After 46.0 Gy, the tumor volume should include the contrast-enhancing lesion (without edema) on the pre-surgery MRI/CT scan plus a 2.5 centimeter margin.

Locations

Country	Name	City	State
United States	Markey Cancer Center at University of Kentucky Chandler Medical Center	Lexington	Kentucky
United States	CCOP - Marshfield Clinic Research Foundation	Marshfield	Wisconsin
United States	South Jersey Regional Cancer Center	Millville	New Jersey
United States	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin
United States	Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital	Mount Holly	New Jersey
United States	Cottonwood Hospital Medical Center	Murray	Utah
United States	Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha	Omaha	Nebraska
United States	Foundation for Cancer Research and Education	Phoenix	Arizona
United States	Utah Valley Regional Medical Center - Provo	Provo	Utah
United States	Dixie Regional Medical Center	Saint George	Utah
United States	LDS Hospital	Salt Lake City	Utah
United States	St. John Health System	Tulsa	Oklahoma
United States	Cancer Treatment Center	Wooster	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Radiation Therapy Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	This study stopped accrual early with 19 subjects accrued out of 72 planned therefore no analyses were performed.	From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months.