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

June 26, 2018 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
    • Florida
      • Tampa, Florida, United States, 33612-9497
        • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute of Emory University
    • Maryland
      • Baltimore, Maryland, United States, 21231-2410
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Josephine Ford Cancer Center at Henry Ford Hospital
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157-1096
        • Wake Forest University Comprehensive Cancer Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-4283
        • Abramson Cancer Center of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

outpatient clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

National Cancer Institute (NCI)
North American Brain Tumor Consortium

Investigators

  • Principal Investigator: Larry Kleinberg, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Principal Investigator: Stuart A. Grossman, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Study Chair: Michael B. Streiff, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

November 11, 2005

First Submitted That Met QC Criteria

November 11, 2005

First Posted (Estimate)

November 15, 2005

Study Record Updates

Last Update Posted (Actual)

June 28, 2018

Last Update Submitted That Met QC Criteria

June 26, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NABTT-0307
  • U01CA062475 (U.S. NIH Grant/Contract)
  • CDR0000441111
  • JHOC-NABTT-0307

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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