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

Johns Hopkins Medicine

Status: Completed

Conditions: Thromboembolism; Brain and Central Nervous System Tumors

Treatments: Procedure: management of therapy complications; Other: laboratory biomarker analysis; Other: physiologic testing

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00253669

JHOC-NABTT-0307

NABTT-0307

CDR0000441111

U01CA062475 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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