Clinical trial NCT00253669: Risk Factors for Developing a Blood Clot in Patients Who Are Undergoing Cancer Treatment for Newly Diagnosed Gliomas
Official title: Pilot Study of Thrombophilic States in Newly Diagnosed Patients With High-Grade Gliomas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain and Central Nervous System Tumors
Thromboembolism
Keywords: thromboembolism
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma
adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: North American Brain Tumor Consortium
First posted: 2005-11-15
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: outpatient clinic

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.

Eligibility 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

Primary outcomes:
measure: Thrombosis-free survival as assessed by objectively documented deep vein thrombosis or pulmonary embolism
timeFrame: until dvt or death
Secondary outcomes:
measure: ABO blood group association with venous thromboembolism (VTE) factor VIII activity and VTE as assessed by laboratory test result at study entry
timeFrame: on study
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
state: Alabama
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute of Emory University
state: Georgia
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Josephine Ford Cancer Center at Henry Ford Hospital
state: Michigan
city: Winston-Salem
country: United States
facility: Wake Forest University Comprehensive Cancer Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Michael B. Streiff, MD
role: STUDY_CHAIR
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Stuart A. Grossman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Larry Kleinberg, MD
role: PRINCIPAL_INVESTIGATOR
References: