Dalteparin and Radiation Therapy in Treating Patients With Newly Diagnosed Supratentorial Gliobla… (NCT00028678) | Clinical Trial Compass
CompletedPhase 2
Dalteparin and Radiation Therapy in Treating Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme
United States45 participantsStarted 2002-07-11
Plain-language 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.
Who can participate
Age range18 Years – 120 Years
SexALL
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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 pou…