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
Verified date | November 2015 |
Source | Radiation Therapy Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Radiation Therapy Oncology Group | National Cancer Institute (NCI) |
United States,
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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