A Phase II Study to Evaluate the Effect of Dalteparin and Radiation Therapy on Survival Compared to the RTOG RPA Database and on Thromboembolic Events in Patients With Newly Diagnosed Glioblastoma Multiforme
- Determine whether dalteparin, initiated at the time of conventional radiotherapy,
improves the median survival of patients with newly diagnosed supratentorial
- Determine the time to progression in patients treated with this regimen.
- Determine the incidence of thromboembolic events in patients treated with this regimen.
- Determine the feasibility and toxicity of dalteparin in this patient population.
OUTLINE: This is a multicenter study.
Patients undergo cranial irradiation 5 days a week for 7 weeks. Beginning concurrently with
initiation of radiotherapy, patients receive dalteparin subcutaneously once daily for up to
2 years in the absence of unacceptable toxicity. Patients may continue receiving dalteparin
after year 2 at the discretion of the investigator.
Patients are followed every 3 months for 2 years and then every 6 months for up to 5 years
after study entry.
PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study.
Primary Purpose: Treatment
H. I. Robins, MD, PhD
University of Wisconsin, Madison
United States: Food and Drug Administration
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|CCOP - Carle Cancer Center||Urbana, Illinois 61801|
|CCOP - Kalamazoo||Kalamazoo, Michigan 49007-3731|
|CCOP - Metro-Minnesota||Saint Louis Park, Minnesota 55416|
|West Michigan Cancer Center||Kalamazoo, Michigan 49007-3731|
|University of Wisconsin Comprehensive Cancer Center||Madison, Wisconsin 53792|
|Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center||Lebanon, New Hampshire 03756-0002|
|Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center||Nashville, Tennessee 37232-2516|
|CCOP - Scott and White Hospital||Temple, Texas 76508|
|CCOP - St. Vincent Hospital Cancer Center, Green Bay||Green Bay, Wisconsin 54301|
|CCOP - Oklahoma||Tulsa, Oklahoma 74136|