Radiation Therapy Followed by Bleomycin in Treating Adult Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme
- Conditions
- Brain and Central Nervous System Tumors
- Interventions
- Biological: bleomycinDevice: Ommaya reservoirRadiation: radiation therapy
- Registration Number
- NCT00006916
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief 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.
- Detailed 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 & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 19
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Radiation therapy followed by bleomycin via Ommaya reservoir Ommaya reservoir 60.0 Gy/30 fractions x 2.0 Gy. Then within 2-6 weeks after completion of radiation therapy or at the time a patient experiences disease progression during or immediately after completion of radiation therapy, if clinically feasible, a modified Ommaya reservoir is implanted with the delivery catheter in the tumor or tumor cyst/cavity. Bleomycin, 15 units per week, is then given via the Ommaya reservoir without interruption for a maximum of two years as long as there is no toxicity above grade 3 or evidence of disease progression. Radiation therapy followed by bleomycin via Ommaya reservoir radiation therapy 60.0 Gy/30 fractions x 2.0 Gy. Then within 2-6 weeks after completion of radiation therapy or at the time a patient experiences disease progression during or immediately after completion of radiation therapy, if clinically feasible, a modified Ommaya reservoir is implanted with the delivery catheter in the tumor or tumor cyst/cavity. Bleomycin, 15 units per week, is then given via the Ommaya reservoir without interruption for a maximum of two years as long as there is no toxicity above grade 3 or evidence of disease progression. Radiation therapy followed by bleomycin via Ommaya reservoir bleomycin 60.0 Gy/30 fractions x 2.0 Gy. Then within 2-6 weeks after completion of radiation therapy or at the time a patient experiences disease progression during or immediately after completion of radiation therapy, if clinically feasible, a modified Ommaya reservoir is implanted with the delivery catheter in the tumor or tumor cyst/cavity. Bleomycin, 15 units per week, is then given via the Ommaya reservoir without interruption for a maximum of two years as long as there is no toxicity above grade 3 or evidence of disease progression.
- Primary Outcome Measures
Name Time Method Overall Survival From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months. This study stopped accrual early with 19 subjects accrued out of 72 planned therefore no analyses were performed.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
Foundation for Cancer Research and Education
🇺🇸Phoenix, Arizona, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
🇺🇸Lexington, Kentucky, United States
South Jersey Regional Cancer Center
🇺🇸Millville, New Jersey, United States
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
🇺🇸Omaha, Nebraska, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
🇺🇸Mount Holly, New Jersey, United States
Cancer Treatment Center
🇺🇸Wooster, Ohio, United States
St. John Health System
🇺🇸Tulsa, Oklahoma, United States
Cottonwood Hospital Medical Center
🇺🇸Murray, Utah, United States
Utah Valley Regional Medical Center - Provo
🇺🇸Provo, Utah, United States
Dixie Regional Medical Center
🇺🇸Saint George, Utah, United States
CCOP - Marshfield Clinic Research Foundation
🇺🇸Marshfield, Wisconsin, United States
Medical College of Wisconsin Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
LDS Hospital
🇺🇸Salt Lake City, Utah, United States