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

NCT ID: NCT00253669

Last Updated: 2018-06-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 110 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2009-08-31

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

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.

Conditions

Brain and Central Nervous System Tumors; Thromboembolism

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Interventions

laboratory biomarker analysis

Intervention Type: OTHER

physiologic testing

Intervention Type: OTHER

management of therapy complications

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

North American Brain Tumor Consortium

OTHER

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael B. Streiff, MD

Role: STUDY_CHAIR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Stuart A. Grossman, MD

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Larry Kleinberg, MD

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

Birmingham, Alabama, United States

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Tampa, Florida, United States

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, United States

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

U01CA062475

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000441111

Identifier Type: -

Identifier Source: secondary_id

JHOC-NABTT-0307

Identifier Type: -

Identifier Source: secondary_id

NABTT-0307

Identifier Type: -

Identifier Source: org_study_id