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

Eastern Cooperative Oncology Group45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Brain and Central Nervous System Tumors

Interventions

dalteparinDRUG

radiation therapyRADIATION

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (12)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

CCOP - Carle Cancer Center

Urbana, Illinois, United States

CCOP - Kalamazoo

Kalamazoo, Michigan, United States

Data from ClinicalTrials.gov

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