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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00006916
Other study ID # RTOG-BR-0013
Secondary ID CDR0000068343
Status Terminated
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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