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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pilot Study of Thrombophilic States in Newly Diagnosed Patients With High-Grade Gliomas

Conditions
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Brain and Central Nervous System Tumors, Thromboembolism

Intervention / Treatment
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* Other: laboratory biomarker analysis
* Other: physiologic testing
* Procedure: management of therapy complications


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: laboratory biomarker analysis|nan|
|Other: physiologic testing|nan|
|Procedure: management of therapy complications|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombosis-free survival as assessed by objectively documented deep vein thrombosis or pulmonary embolism |  | until dvt or death | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ABO blood group association with venous thromboembolism (VTE) factor VIII activity and VTE as assessed by laboratory test result at study entry |  | on study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thromboembolism, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma