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.

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