Dalteparin and Radiation Therapy in Treating Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Brain and Central Nervous System Tumors

Intervention / Treatment
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* Drug: dalteparin
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: dalteparin|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma