Treatment of Blood Clots in Children With Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Eisai Inc.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00952380
First received: August 4, 2009
Last updated: December 20, 2012
Last verified: December 2012
  Purpose

The purpose of this study is to determine dosing recommendations when given subcutaneously twice daily along with long term safety information in evaluating thrombus resolution at day 90.


Condition Intervention Phase
Venous Thromboembolism
Drug: Fragmin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Three Month Prospective Open Label Study Of Therapy With Fragmin (Dalteparin Sodium Injection) In Children With Malignancies And Venous Thromboembolism

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Efficacy: Thrombus resolution at the end of study or early termination visit will be measured by repeating the same imaging method used at baseline. [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety Outcomes will consist of major bleeding episodes, recurrent DVT/Pulmonary embolism and unexpected serious adverse events (SAEs). [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: February 2010
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Fragmin
Subject's age 0-2 months (newborns) will receive an initial dose of 125 IU/kg. Subject's age 2 months to 12 months (infants) will receive an initial dose of 150 IU/kg. Subjects age 12 months through 12 years (preschool and school) will receive an initial dose of 125 IU/kg. Subjects age 12 to 18 years (teen) will receive an initial dose of 100 IU/kg. All subjects will have dose adjustments in 25 IU/kg increments/decrements based upon an anti-Xa therapeutic goal range of 0.5 - 1.0 U/mL.
Other Name: Dalteparin sodium

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have an active malignancy (defined as a diagnosis of cancer, other than basal cell or squamous cell carcinoma of the skin).
  2. Have been objectively diagnosed with thrombosis involving a deep vein (documented using compression ultrasound with Doppler [CUD], computed tomography with/without venography [CT/CTV], magnetic resonance imaging with/without venography [MRI/MRV], conventional venography [CV]) or pulmonary artery (ventilation-perfusion scan [V/Q], spiral CT angiography [SCTA], or conventional pulmonary angiogram [CPA]) within the 96 hours of enrollment, and require anticoagulation therapy.
  3. Are judged clinically to require anticoagulation therapy.
  4. Are in the age range of ≥ 36 weeks gestation and < 19 years.
  5. Have given signed informed consent (and assent, as appropriate) to participate prior to enrollment.

Exclusion Criteria:

  1. Weight ≤ 3.0 kg or > 100 kg.
  2. Platelet count ≤ 50,000/mm3 (despite appropriate medical measures to support platelet count).
  3. Received oral anticoagulant therapy within 72 hours of enrollment.
  4. History of administration of therapeutic doses of LMWH or unfractionated heparin for a treat period of > 96 hours (or > 8 doses of LMWH) for the qualifying VTE.
  5. Received unfractionated heparin within 3 hours, or LMWH within 15 hours of the first dose of dalteparin.
  6. Acute VTE intervention which includes thrombolytic therapy.
  7. Major bleeding at the time of screening or enrollment or an unacceptably high risk of bleeding at the discretion of the investigator.
  8. aPTT > 5 seconds above ULN, and that corrects to within normal limits upon 1:1 mixing with normal plasma.
  9. PT > 2 seconds above ULN, and that corrects to within normal limits upon 1:1 mixing with normal plasma.
  10. Calculated creatinine clearance (Schwartz method) < 60 mL/min in subjects > 1 month of age.
  11. Uncontrolled hypertension characterized by a sustained systolic pressure or diastolic pressure > 99th percentile of age- and height-related norms.
  12. History of heparin-induced thrombocytopenia (HIT).
  13. Any condition in which the investigator feels the subject is unsafe or inappropriate for study participation.
  14. Insufficient subcutaneous tissue to facilitate subcutaneous drug administration.
  15. Presently or previously received (within 30 days of enrollment) study drug for which an IND/IDE is in effect, with the exception of erwinia asparaginase.
  16. Pregnant or lactating female.
  17. Refusal by sexually active post-menarche female subjects to adhere to an acceptable form of contraception.
  18. Unable or unwilling to comply with scheduled follow-up visits.
  19. Inability to obtain written informed consent from subject or parent or legally acceptable representative for the subject.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00952380

Contacts
Contact: Martha Kennedy 201-746-2780 martha_kennedy@eisai.com
Contact: Chad McQueen chad_mcqueen@eisai.com

Locations
United States, Arkansas
Arkansas Children's Hospital Research Institute Recruiting
Little Rock, Arkansas, United States, 72202
Contact: Robert Saylors, MD    501-364-1494    saylorsRobertL@uams.edu   
Principal Investigator: Robert Saylors, MD         
United States, California
Stanford University Medical Center Recruiting
Palo Alto, California, United States, 94304
Contact: Neyssa Marina, MD    650-723-5535    neyssa.marina@stanford.edu   
Principal Investigator: Neyssa Marina, MD         
United States, District of Columbia
Georgetown University Lombardi Cancer Center Recruiting
Washington, District of Columbia, United States, 20007-2197
Contact: Aziza Shad, MD    202-444-2224    shada@georgetown.edu   
Principal Investigator: Aziza Shad, MD         
United States, Florida
Nemours Children's Clinic/Jacksonville Recruiting
Jacksonville, Florida, United States, 32207
Contact: Cynthia Gauger, MD    904-390-3600    cgauger@nemours.org   
Principal Investigator: Cynthia Gauger, MD         
St. Joseph's Children's Hospital of TampaPediatric Hematology/Oncology Research Department Recruiting
Tampa, Florida, United States, 33607-6307
Contact: Cameron Tebbi, MD    813-870-4252    cameron.tebbi@baycare.org   
Principal Investigator: Cameron Tebbi, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Michael Briones, DO       michael.briones@choa.org   
Principal Investigator: Michael Briones. DO         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Leonard Valentino, MD    312-942-8975    lvalentino@rush.edu   
Principal Investigator: Leonard Valentino, MD         
United States, Indiana
Peyton Manning Childrens Hospital at St. Vincent Pediatric Oncology Active, not recruiting
Indianapolis, Indiana, United States, 46260
United States, Kentucky
Kosair Charities Pediatric Clinical Research Unit- University of Louisville Recruiting
Louisvile, Kentucky, United States, 40202
Contact: Janice Sullivan, MD    502-629-5820    sully@louisville.edu   
Principal Investigator: Janice Sullivan, MD         
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Prasad Mathew, MD    505-272-4461    Pmathew@salud.unm.edu   
Principal Investigator: Prasad Mathew, MD         
United States, North Carolina
Duke Children's Hospital Recruiting
Durham, North Carolina, United States, 27710
Contact: Cassandra Moran, MD       cassandra.moran@duke.edu   
Principal Investigator: Cassandra Moran, MD         
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Michael Recht,MD    503-494-0829    rechtm@ohsu.edu   
Principal Investigator: Michael Recht,MD         
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105-3678
Contact: Scott Howard, MD    901-595-3901    scott.howard@stjude.org   
Principal Investigator: Scott Howard,MD         
United States, Texas
Cook Children's Medical Center Recruiting
Forth Worth, Texas, United States, 76104
Contact: Marcela Torres, MD    682-885-4018    marcela.torres@cookchildrens.org   
Principal Investigator: Marcela Torres,MD         
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Chair: Neil Goldenberg, MD,PhD Univ. of Colorado and The Childrens Hospital
Principal Investigator: Margaret Macy, MD Univ. of Colorado and The Childrens Hospital
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00952380     History of Changes
Other Study ID Numbers: FRAG-A001-201
Study First Received: August 4, 2009
Last Updated: December 20, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Dalteparin
Heparin, Low-Molecular-Weight
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 21, 2014