Status:
UNKNOWN
Tinzaparin in Treating Patients With Metastatic Kidney Cancer That Cannot Be Removed By Surgery
Lead Sponsor:
University of Vermont
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Kidney Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Tinzaparin may stop the growth of kidney cancer by blocking blood flow to the tumor. PURPOSE: This phase I/II trial is studying the side effects of tinzaparin and to see how well it works ...
Detailed Description
OBJECTIVES: Primary * Determine the effect of tinzaparin sodium on fibrin formation (prothrombin fragment F1.2), thrombin generation (thrombin-antithrombin complexes), and fibrinolysis (D-Dimer) fro...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed renal cell carcinoma of clear cell histology
- Tumors of mixed histology eligible if ≥ 50% of tumor has clear cell histology
- No nonclear cell histologies, collecting duct tumors, oncocytomas, or transitional cell tumors
- Metastatic and unresectable disease that is clinically extending beyond the regional lymph nodes (histological confirmation not required)
- Patients who are inoperable for their primary tumor representing the sole site of disease are ineligible
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 2 cm by conventional techniques OR ≥ 1 cm by spiral CT scan
- No known brain metastases
- PATIENT CHARACTERISTICS:
- Expected survival \> 2 months
- CALGB (ECOG/ZUBROD) performance status (PS) 0-2 OR Karnofsky PS 60-100%
- Hemoglobin ≥ 10 g/dL
- Platelet count ≥ 100,000/mm\^3
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST/ALT ≤ 1.5 times ULN
- Creatinine ≤ 1.5 times ULN
- INR ≤ 1.5 times control value
- PTT \< 1.5 times control value
- Negative pregnancy test
- Fertile patients must use effective contraception
- Patients must be able to receive subcutaneous injections at home
- No other primary malignancy in the past 5 years other than basal cell carcinoma or carcinoma in situ of the cervix that has been curatively treated and is associated with a less than 30% risk of relapse in the next 5 years
- No signs or symptoms of bleeding within 4 the past weeks
- No known bleeding diathesis or high risk for bleeding due to any condition, including trauma within the past 4 weeks, active current bleeding, or hemorrhagic stroke or intraocular bleeding within the past 6 months
- No active thromboembolism highly likely to require anticoagulation during the study period
- No known or suspected history of type II heparin-induced thrombocytopenia
- No allergy or hypersensitivity to heparin, tinzaparin sodium, pork products, sulfite, or benzyl alcohol
- No uncontrolled severe intercurrent illness, including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- No uncontrolled arterial hypertension, history of gastrointestinal ulceration, and/or bleeding in the past 4 weeks
- No diabetic retinopathy or history of retinal hemorrhage
- Not pregnant or nursing
- HIV-positive patients are allowed
- PRIOR CONCURRENT THERAPY:
- No treatment with anticoagulation lasting \> 1 month in the past 6 months
- No anticoagulation, including treatment with a low molecular weight heparin, at any time within the past month
- More than 4 weeks since prior surgery, radiation therapy, immunotherapy, or chemotherapy
- Recovered from prior therapy
- No other concurrent investigational agents
- No other concurrent anticoagulation therapy, including oral anticoagulants, thrombolytic agents, or any form of heparin
- Concurrent antiplatelet agents allowed
- No spinal or epidural puncture, anesthesia, or post-operative indwelling epidural catheters within the past 48 hours
- No other concurrent anticancer agents or therapies
- No concurrent sex hormones except for postmenopausal hormone replacement
- No concurrent chemotherapy or immunotherapy
- No concurrent palliative radiotherapy
- Concurrent urgent use of corticosteroids allowed
Exclusion
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00293501
Start Date
December 1 2005
Last Update
November 6 2013
Active Locations (3)
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1
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
2
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
3
Vermont Cancer Center at University of Vermont
Burlington, Vermont, United States, 05405-0110