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.

Condition	Treatment or Intervention	Phase
adult glioblastoma adult giant cell glioblastoma adult gliosarcoma	Drug: dalteparin  Procedure: anti-cytokine therapy  Procedure: antiangiogenesis therapy  Procedure: anticoagulation  Procedure: biological response modifier therapy  Procedure: growth factor antagonist therapy  Procedure: radiation therapy  Procedure: supportive care/therapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Florida
      H. Lee Moffitt Cancer Center and Research Institute, Tampa,  Florida,  33612-9497,  United States
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States
Michigan
      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States
      West Michigan Cancer Center, Kalamazoo,  Michigan,  49007,  United States
Minnesota
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
New Hampshire
      Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon,  New Hampshire,  03756-0002,  United States
Oklahoma
      CCOP - Oklahoma, Tulsa,  Oklahoma,  74136,  United States
Tennessee
      Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville,  Tennessee,  37232-6307,  United States
Texas
      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States
Wisconsin
      CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay,  Wisconsin,  54307-3453,  United States
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-0001,  United States

Study chairs or principal investigators

H. Ian Robins, MD, PhD,  Study Chair,  University of Wisconsin Comprehensive Cancer Center   

Study ID Numbers:  CDR0000069119; ECOG-E1F01
Record last reviewed:  November 2004
Last Updated:  November 4, 2004
Record first received:  January 4, 2002
ClinicalTrials.gov Identifier:  NCT00028678
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08