Status:

COMPLETED

Risk Factors for Developing a Blood Clot in Patients Who Are Undergoing Cancer Treatment for Newly Diagnosed Gliomas

Lead Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborating Sponsors:

National Cancer Institute (NCI)

North American Brain Tumor Consortium

Conditions:

Brain and Central Nervous System Tumors

Thromboembolism

Eligibility:

All Genders

18-120 years

Brief Summary

RATIONALE: Patients with gliomas may be at risk for developing blood clots. Learning about the risk factors for developing blood clots may help doctors plan better treatment for gliomas. PURPOSE: Thi...

Detailed Description

OBJECTIVES: Primary * Determine the overall hazard rate of first venous thromboembolism per person-year of follow-up in patients undergoing antineoplastic therapy for newly diagnosed high-grade glio...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed newly diagnosed malignant brain tumor
  • Supratentorial grade III or IV astrocytoma of 1 of the following types:
  • Anaplastic astrocytoma
  • Anaplastic oligodendroglioma
  • Glioblastoma multiforme
  • No prior thrombotic event
  • PATIENT CHARACTERISTICS:
  • Performance status
  • Karnofsky 60-100%
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Not specified
  • Hepatic
  • Not specified
  • Renal
  • Not specified
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • No prior immunotherapy or biologic agents, including immunotoxins, immunoconjugates, antisense therapy, peptide-receptor antagonists, interferons, interleukins, tumor-infiltrating lymphocytes, lymphocyte-activated killer cells, or gene therapy, for the brain tumor
  • Chemotherapy
  • No prior chemotherapy for the brain tumor except polifeprosan 20 with carmustine implant (Gliadel wafer)
  • Endocrine therapy
  • No prior hormonal therapy for the brain tumor except glucocorticoids
  • Radiotherapy
  • No prior radiotherapy for the brain tumor
  • No prior cranial irradiation
  • Other
  • No concurrent chronic anticoagulation therapy

Exclusion

    Key Trial Info

    Start Date :

    April 1 2005

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    August 1 2009

    Estimated Enrollment :

    110 Patients enrolled

    Trial Details

    Trial ID

    NCT00253669

    Start Date

    April 1 2005

    End Date

    August 1 2009

    Last Update

    June 28 2018

    Active Locations (9)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (9 locations)

    1

    Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

    Birmingham, Alabama, United States, 35294

    2

    H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

    Tampa, Florida, United States, 33612-9497

    3

    Winship Cancer Institute of Emory University

    Atlanta, Georgia, United States, 30322

    4

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, United States, 21231-2410