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


Phase 2
N/A
18 Years
Open (Enrolling)
Both
Venous Thromboembolism

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

90 days

Safety Issue:

No

Principal Investigator

Neil Goldenberg, MD,PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Univ. of Colorado and The Childrens Hospital

Authority:

United States: Institutional Review Board

Study ID:

FRAG-A001-201

NCT ID:

NCT00952380

Start Date:

February 2010

Completion Date:

Related Keywords:

  • Venous Thromboembolism
  • Thromboembolism
  • Venous Thromboembolism
  • Venous Thrombosis

Name

Location

Stanford University Medical CenterStanford, California  94305-5408
Rush University Medical CenterChicago, Illinois  60612-3824
St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Emory UniversityAtlanta, Georgia  30322
University of New MexicoAlbuquerque, New Mexico  87131
Oregon Health and Science UniversityPortland, Oregon  97201
Cook Children's Medical CenterFort Worth, Texas  76104
Georgetown University Lombardi Cancer CenterWashington, District of Columbia  20007
Arkansas Children's Hospital Research InstituteLittle Rock, Arkansas  72202
Nemours Children's Clinic/JacksonvilleJacksonville, Florida  32207
St. Joseph's Children's Hospital of TampaPediatric Hematology/Oncology Research DepartmentTampa, Florida  33607-6307
Peyton Manning Childrens Hospital at St. Vincent Pediatric OncologyIndianapolis, Indiana  46260
Kosair Charities Pediatric Clinical Research Unit- University of LouisvilleLouisvile, Kentucky  40202
Duke Children's HospitalDurham, North Carolina  27710