Radiation Therapy Followed by Bleomycin in Treating Adult Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme
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.
|Brain and Central Nervous System Tumors||Biological: bleomycin Device: Ommaya reservoir Radiation: radiation therapy||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
- Overall Survival [ Time Frame: 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.
|Study Start Date:||June 2001|
|Study Completion Date:||December 2005|
|Primary Completion Date:||December 2005 (Final data collection date for primary outcome measure)|
Experimental: Radiation therapy followed by bleomycin via 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.
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006916
|United States, Arizona|
|Foundation for Cancer Research and Education|
|Phoenix, Arizona, United States, 85013|
|United States, Kentucky|
|Markey Cancer Center at University of Kentucky Chandler Medical Center|
|Lexington, Kentucky, United States, 40536-0293|
|United States, Nebraska|
|Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha|
|Omaha, Nebraska, United States, 68114-4199|
|United States, New Jersey|
|South Jersey Regional Cancer Center|
|Millville, New Jersey, United States, 08332|
|Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital|
|Mount Holly, New Jersey, United States, 08060|
|United States, Ohio|
|Cancer Treatment Center|
|Wooster, Ohio, United States, 44691|
|United States, Oklahoma|
|St. John Health System|
|Tulsa, Oklahoma, United States, 74104|
|United States, Utah|
|Cottonwood Hospital Medical Center|
|Murray, Utah, United States, 84107|
|Utah Valley Regional Medical Center - Provo|
|Provo, Utah, United States, 84604|
|Dixie Regional Medical Center|
|Saint George, Utah, United States, 84770|
|Salt Lake City, Utah, United States, 84143|
|United States, Wisconsin|
|CCOP - Marshfield Clinic Research Foundation|
|Marshfield, Wisconsin, United States, 54449|
|Medical College of Wisconsin Cancer Center|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Roy A. Patchell, MD||Lucille P. Markey Cancer Center at University of Kentucky|