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Treatment of Blood Clots in Children With Cancer

Information source: Eisai Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Venous Thromboembolism

Intervention: Fragmin (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Eisai Inc.

Official(s) and/or principal investigator(s):
Neil Goldenberg, MD,PhD, Study Chair, Affiliation: Univ. of Colorado and The Childrens Hospital
Scott Howard, MD, Principal Investigator, Affiliation: St. Jude Children's Research Hospital

Overall contact:
Vincenzo Maddalena, Phone: 201-746-2332, Email: vincenzo_maddalena@eisai.com

Summary

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.

Clinical Details

Official title: A Three Month Prospective Open Label Study Of Therapy With Fragmin (Dalteparin Sodium Injection) In Children With Malignancies And Venous Thromboembolism

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Efficacy: Thrombus resolution at the end of study or early termination visit will be measured by repeating the same imaging method used at baseline.

Secondary outcome: Safety Outcomes will consist of major bleeding episodes, recurrent DVT/Pulmonary embolism and unexpected serious adverse events (SAEs).

Eligibility

Minimum age: N/A. Maximum age: 18 Years. Gender(s): Both.

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 greater than or equal to 36 weeks gestation and less than 19 years. 5. Have given signed informed consent (and assent, as appropriate) to participate prior to enrollment. Exclusion Criteria: 1. Weight less than or equal to 3. 0 kg or greater than 100 kg. 2. Platelet count less than or equal to 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 greater than 96 hours (or greater than 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 greater than 5 seconds above ULN, and that corrects to within normal limits upon 1: 1 mixing with normal plasma. 9. PT greater than 2 seconds above ULN, and that corrects to within normal limits upon 1: 1 mixing with normal plasma. 10. Calculated creatinine clearance (Schwartz method) less than 60 mL/min in subjects greater than 1 month of age. 11. Uncontrolled hypertension characterized by a sustained systolic pressure or diastolic pressure greater than 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.

Locations and Contacts

Vincenzo Maddalena, Phone: 201-746-2332, Email: vincenzo_maddalena@eisai.com

Arkansas Children's Hospital Research Institute, Little Rock, Arkansas 72202, United States; Recruiting
Robert Saylors, MD, Phone: 501-364-1494, Email: saylorsRobertL@uams.edu
Robert Saylors, MD, Principal Investigator

Stanford University Medical Center, Palo Alto, California 94304, United States; Recruiting
Neyssa Marina, MD, Phone: 650-723-5535, Email: neyssa.marina@stanford.edu
Neyssa Marina, MD, Principal Investigator

Georgetown University Lombardi Cancer Center, Washington, District of Columbia, United States; Recruiting
Aziza Shad, MD, Phone: 202-444-2224, Email: shada@georgetown.edu
Aziza Shad, MD, Principal Investigator

Nemours Children's Clinic-Jacksonville, Jacksonville, Florida 32207, United States; Recruiting
Cynthia Gauger, MD, Phone: 904-390-3600, Email: cgauger@nemours.org
Cynthia Gauger, MD, Principal Investigator

St. Joseph's Children's Hospital of TampaPediatric Hematology-Oncology Research Department, Tampa, Florida, United States; Recruiting
Cameron Tebbi, MD, Phone: 813-870-4252, Email: cameron.tebbi@baycare.org
Cameron Tebbi, MD, Principal Investigator

Emory University, Atlanta, Georgia 30322, United States; Recruiting
Michael Briones, DO, Email: michael.briones@choa.org
Michael Briones, DO, Principal Investigator

Rush University Medical Center, Chicago, Illinois 60612, United States; Recruiting
Leonard Valentino, MD, Phone: 312-942-8975, Email: lvalentino@rush.edu
Leonard Valentino, MD, Principal Investigator

Peyton Manning Childrens Hospital at St. Vincent Pediatric Oncology, Indianapolis, Indiana 46260, United States; Active, not recruiting

Kosair Charities Pediatric Clinical Research Unit-University of Louisville, Louisvile, Kentucky 40202, United States; Recruiting
Janice Sullivan, MD, Phone: 502-629-5820, Email: sully@louisville.edu
Janice Sullivan, MD, Principal Investigator

University of New Mexico, Albuquerque, New Mexico 87131, United States; Recruiting
Prasad Mathew, MD, Phone: 505-272-4461, Email: Pmathew@salud.unm.edu
Prasad Mathew, MD, Principal Investigator

Duke Children's Hospital, Durham, North Carolina 27710, United States; Recruiting
Cassandra Moran, MD, Email: cassandra.moran@duke.edu
Cassandra Moran, MD, Principal Investigator

Oregon Health and Science University, Portland, Oregon 97239, United States; Recruiting
Michael Recht, MD, Phone: 503-494-0829, Email: rechtm@ohsu.edu
Michael Recht, MD, Principal Investigator

St. Jude Children's Research Hospital, Memphis, Tennessee, United States; Recruiting
Scott Howard, MD, Phone: 901-595-3901, Email: scott.howard@stjude.org
Scott Howard, MD, Principal Investigator

Cook Children's Medical Center, Forth Worth, Texas 76104, United States; Recruiting
Marcela Torres, MD, Phone: 682-885-4018, Email: marcela.torres@cookchildrens.org
Marcela Torres, MD, Principal Investigator

Additional Information

Starting date: February 2010
Last updated: January 19, 2015

Page last updated: August 20, 2015

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