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
- Determine the median survival time of patients with newly diagnosed supratentorial
glioblastoma multiforme treated with radiotherapy followed by sustained release
- 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
PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 5 months.
Primary Purpose: Treatment
Roy A. Patchell, MD
Lucille P. Markey Cancer Center at University of Kentucky
United States: Federal Government
|Medical College of Wisconsin Cancer Center||Milwaukee, Wisconsin 53226|
|Dixie Regional Medical Center||Saint George, Utah 84770|
|LDS Hospital||Salt Lake City, Utah 84143|
|Utah Valley Regional Medical Center - Provo||Provo, Utah 84604|
|Foundation for Cancer Research and Education||Phoenix, Arizona 85013|
|South Jersey Regional Cancer Center||Millville, New Jersey 08332|
|St. John Health System||Tulsa, Oklahoma 74104|
|Markey Cancer Center at University of Kentucky Chandler Medical Center||Lexington, Kentucky 40536-0084|
|Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital||Mount Holly, New Jersey 08060|
|Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha||Omaha, Nebraska 68114-4199|
|CCOP - Marshfield Clinic Research Foundation||Marshfield, Wisconsin 54449|
|Cottonwood Hospital Medical Center||Murray, Utah 84107|
|Cancer Treatment Center||Wooster, Ohio 44691|