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)
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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