Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Risk Factors for Developing a Blood Clot in Patients Who Are Undergoing Cancer Treatment for Newly Diagnosed Gliomas
This study is ongoing, but not recruiting participants.
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00253669
  Purpose

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: This clinical trial is studying risk factors for developing blood clots in patients who are undergoing cancer treatment for newly diagnosed gliomas.


Condition Intervention
Brain and Central Nervous System Tumors
Cancer-Related Problem/Condition
Procedure: laboratory biomarker analysis
Procedure: management of therapy complications
Procedure: physiologic testing

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Observational
Official Title: Pilot Study of Thrombophilic States in Newly Diagnosed Patients With High-Grade Gliomas

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Thrombosis-free survival as assessed by objectively documented deep vein thrombosis or pulmonary embolism

Secondary Outcome Measures:
  • ABO blood group association with venous thromboembolism (VTE) factor VIII activity and VTE as assessed by laboratory test result at study entry

Estimated Enrollment: 107
Study Start Date: April 2005
Estimated Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
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 gliomas.
  • Correlate ABO blood type with incidence of venous thromboembolism in these patients.
  • Correlate factor VIII level with incidence of venous thromboembolism in these patients.

Secondary

  • Determine the overall and individual incidence rate of thromboembolism in these patients.
  • Correlate clinical variables, such as type of antineoplastic treatments, Karnofsky performance status, and type of tumor, with incidence of venous thromboembolism in these patients.
  • Correlate demographic factors, such as age, with incidence of venous thromboembolism in these patients.

OUTLINE: This is a pilot, multicenter study.

Patients undergo blood collection for blood typing (if not already obtained) and factor VIII and C-reactive protein levels at baseline. Patients are followed to obtain information on their Karnofsky performance status, treatment they receive for their brain tumor, and occurrence of any thrombotic events (e.g., pulmonary embolism or deep-vein thrombosis). Patients are followed every 28 days until the development of thrombotic events, after which they are followed every 2 months for survival.

PROJECTED ACCRUAL: A total of 107 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00253669

Locations
United States, Alabama
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497
United States, Georgia
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
Sponsors and Collaborators
Investigators
Study Chair: Michael B. Streiff, MD Sidney Kimmel Comprehensive Cancer Center
Investigator: Stuart A. Grossman, MD Sidney Kimmel Comprehensive Cancer Center
Investigator: Larry Kleinberg, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000441111, NABTT-0307, JHOC-NABTT-0307
Study First Received: November 11, 2005
Last Updated: October 18, 2008
ClinicalTrials.gov Identifier: NCT00253669  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
thromboembolism
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma
adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma

Study placed in the following topic categories:
Glioblastoma
Astrocytoma
Oligodendroglioma
Glioma
Central Nervous System Neoplasms
Gliosarcoma
Thromboembolism
Nervous System Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009