dalteparin and radiation therapy in treating patients with newly diagnosed supratentorial glioblastoma multiforme

Conditions: Brain and Central Nervous System Tumors

Summary: 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.

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.

Eligibility 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

Keywords: adult glioblastoma adult giant cell glioblastoma adult gliosarcoma