Trial Information

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

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.