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
18 Years
N/A
Both
Brain and Central Nervous System Tumors
Trial Information
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
OBJECTIVES:
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed newly diagnosed supratentorial glioblastoma
multiforme
- At least 2 weeks but no more than 4 weeks since prior surgery
- Patients with biopsy only must be at least 1 week past surgery
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Platelet count at least 100,000/mm^3
- No history of heparin-induced thrombocytopenia
- No coagulopathy
Hepatic:
- Bilirubin no greater than 2.5 mg/dL
- AST no greater than 3 times upper limit of normal (ULN)
- PT/aPTT no greater than 1.5 times ULN
Renal:
- Creatinine no greater than 2.0 mg/dL
- No gross hematuria within the past 6 months
Cardiovascular:
- No uncontrolled hypertension
- No unstable angina
- No symptomatic congestive heart failure
- No myocardial infarction within the past 6 months
- No uncontrolled cardiac arrhythmia
Gastrointestinal:
- No peptic ulcer disease within the past 6 months
- Negative stool guaiac
- Negative endoscopy required if positive stool guaiac
Other:
- No known hypersensitivity to dalteparin, heparin, or pork products
- No CNS trauma within the past 3 months
- No intracranial or intraocular hemorrhage, unless related to surgery, within the past
6 months
- No retinal detachment within the past 6 months
- No other concurrent malignancy receiving treatment
- No active infection
- No AIDS-related illness
- HIV negative
- Must weigh at least 90 pounds (40 kg)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent immunomodulators
- No concurrent investigational matrix metalloproteinase inhibitors or antiangiogenesis
agents
Chemotherapy:
- Prior chemotherapy for other malignancy allowed
- No concurrent standard or investigational cytotoxic chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior cranial irradiation
- Prior radiotherapy for other malignancy allowed
- Concurrent radiotherapy allowed
Surgery:
- See Disease Characteristics
- Recovered from prior surgery
- No prior eye or ear surgery
Other:
- No concurrent nonsteroidal anti-inflammatory drugs
- No ongoing or concurrent aspirin or anticoagulation therapy except routine central
venous catheter flushing
- No other concurrent non-protocol therapy
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
H. I. Robins, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Wisconsin, Madison
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000069119
NCT ID:
NCT00028678
Start Date:
May 2002
Completion Date:
Related Keywords:
- Brain and Central Nervous System Tumors
- adult glioblastoma
- adult giant cell glioblastoma
- adult gliosarcoma
- Glioblastoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
Name | Location |
|---|---|
| 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 |
