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

This study has been completed.
Study NCT00028678.   Last updated on August 6, 2008.   Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Dalteparin and Radiation Therapy in Treating Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme
Official Title  A Phase II Study to Evaluate the Effect of Dalteparin and Radiation Therapy on Survival Compared to the RTOG RPA Database and on Thromboembolic Events in Patients With Newly Diagnosed Glioblastoma Multiforme
Brief 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.

Detailed Description

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 Phase Phase II
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Brain and Central Nervous System Tumors
Intervention  Drug: dalteparin
Procedure: radiation therapy
MEDLINE PMIDs 17882417
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date  May 2002
Completion Date
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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00028678
Organization ID CDR0000069119
Secondary IDs †† ECOG-E1F01
Study Sponsor  Eastern Cooperative Oncology Group
Collaborators †† National Cancer Institute (NCI)
Investigators 
Study Chair:     H. I. Robins, MD, PhD     University of Wisconsin, Madison    
Information Provided By National Cancer Institute (NCI)
Verification Date February 2004
First Received Date  January 4, 2002
Last Updated Date August 6, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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