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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dalteparin; Heparin, Low-Molecular-Weight; Tinzaparin

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