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Dalteparin and Radiation Therapy in Treating Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme
This study has been completed.
Study NCT00028678   Information provided by National Cancer Institute (NCI)
First Received: January 4, 2002   Last Updated: February 6, 2009   History of Changes

January 4, 2002
February 6, 2009
May 2002
July 2008   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00028678 on ClinicalTrials.gov Archive Site
 
 
 
Dalteparin and Radiation Therapy in Treating Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme
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

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.

Phase II
Interventional
Treatment
Brain and Central Nervous System Tumors
  • Drug: dalteparin
  • Radiation: radiation therapy
 
Robins HI, O'neill A, Gilbert M, Olsen M, Sapiente R, Berkey B, Mehta M. Effect of dalteparin and radiation on survival and thromboembolic events in glioblastoma multiforme: a phase II ECOG trial. Cancer Chemother Pharmacol. 2007 Sep 20; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
July 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00028678
 
CDR0000069119, ECOG-E1F01
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: H. I. Robins, MD, PhD University of Wisconsin, Madison
National Cancer Institute (NCI)
February 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP