Dalteparin and Radiation Therapy in Treating Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme
RATIONALE: Dalteparin may stop the growth of cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for tumor cell growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining dalteparin with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining dalteparin with radiation therapy in treating patients who have newly diagnosed supratentorial glioblastoma multiforme.
|Brain and Central Nervous System Tumors||Drug: dalteparin Radiation: radiation therapy||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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|
|Study Start Date:||May 2002|
|Primary Completion Date:||July 2006 (Final data collection date for primary outcome measure)|
- Determine whether dalteparin, initiated at the time of conventional radiotherapy, improves the median survival of patients with newly diagnosed supratentorial glioblastoma multiforme.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00028678
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612-9497|
|United States, Illinois|
|CCOP - Carle Cancer Center|
|Urbana, Illinois, United States, 61801|
|United States, Michigan|
|CCOP - Kalamazoo|
|Kalamazoo, Michigan, United States, 49007-3731|
|West Michigan Cancer Center|
|Kalamazoo, Michigan, United States, 49007|
|United States, Minnesota|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|CCOP - Metro-Minnesota|
|Saint Louis Park, Minnesota, United States, 55416|
|United States, New Hampshire|
|Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756-0002|
|United States, Oklahoma|
|CCOP - Oklahoma|
|Tulsa, Oklahoma, United States, 74136|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center|
|Nashville, Tennessee, United States, 37232-6307|
|United States, Texas|
|CCOP - Scott and White Hospital|
|Temple, Texas, United States, 76508|
|United States, Wisconsin|
|CCOP - St. Vincent Hospital Cancer Center, Green Bay|
|Green Bay, Wisconsin, United States, 54307-3453|
|University of Wisconsin Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792-0001|
|Study Chair:||H. I. Robins, MD, PhD||University of Wisconsin, Madison|