View Trial - USC/Norris Cancer Center Clinical Trials

Details for trial 0S-04-5

Description:	Tinzaparin for Primary Treatment and Extended Secondary Prophylaxis of Venous Thromboembolism in Patients with Cancer.
Status:	Open
Randomized?	No

Researchers

Principal Investigator	Title
Howard Liebman	M.D.

Data Management

Name	Title
Laurie Hornor	R.N.
Melissa Peralta	D.M.

You may participate in this study if:

	Requirement
1	Diagnosis of active cancer. Must have documented or recurrent malignancy meeting at least one of the following criteria: (a) diagnosis of cancer within 6 months, excluding squamous cell or basal cell skin cancer; (b) received any treatment for cancer within the previous 6 months; or (c) currently receiving any treatment [surgery, RT, chemotherapy, hormonal therapy, biotherapy, palliative therapy, and/or combined modality therapy] for cancer.
2	Documented first venous thromboembolic event. Must have at least one of the following criteria: (a) DVT of the lower extremity confirmed with duplex ultrasonography, MRI, or venogram, or (b) PE confirmed with high probability V/Q scan, CT angiogram, or pulmonary angiogram.
3	ECOG PS 0, 1, or 2.
4	At least 18 years of age.
5	Signed informed consent (including HIPAA authorization).

You may not participate in this study if:

1	Body weight <40 kg.
2	Recurrent spontaneous fractures unrelated to underlying malignancy.
3	Administration of therapeutic doses of unfractionated or LMW heparin for >48 hours prior to randomization.
4	Need for long-term oral anti-coagulation therapy, e.g., mechanical heart valves, AF.
5	Serious hemorrhage requiring hospitalization, transfusion, or surgical intervention within 2 weeks of presentation.
6	Known acute (symptomatic or active bleeding) gastroduodenal ulcer.
7	Epidural/spinal puncture within the last 24 hours.
8	Neurosurgery within 4 weeks of presentation or any previous history of intracranial hemorrhage.
9	Septic endocarditis.
10	Overt pericardial effusion.
11	Current platelet count <50,000.
12	Undergoing high-dose chemotherapy for PBSC or BMT, induction chemotherapy for acute leukemia, or has other conditions associated with persistent thrombocytopenia of <100,000 for a duration of at least 4 consecutive weeks.
13	Familial bleeding diathesis.
14	Uncontrolled HTN despite anti-hypertensive therapy.
15	Dependent upon renal dialysis or significant renal failure with creatinine >3 x uln.
16	Allergy to heparin (unfractionated or LMW).
17	Allergy to contrast medium.
18	Pregnant or of childbearing potential and not using adequate contraception.
19	Geographically inaccessible for follow-up.

For further information on, or to sign up for this study, please contact the Clinical Investigation Support Office at (323) 865-0451 or the Principal Investigator noted above.