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
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.
Interventional
Primary Purpose: Treatment
Roy A. Patchell, MD
Study Chair
Lucille P. Markey Cancer Center at University of Kentucky
United States: Federal Government
CDR0000068343
NCT00006916
June 2001
Name | Location |
---|---|
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 |