Tinzaparin in Treating Patients With Metastatic Kidney Cancer That Cannot Be Removed By Surgery
Kidney Cancer
About this trial
This is an interventional treatment trial for Kidney Cancer focused on measuring clear cell renal cell carcinoma, stage IV renal cell cancer, recurrent renal cell cancer
Eligibility Criteria
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
Sites / Locations
- University of Chicago Cancer Research Center
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
- Vermont Cancer Center at University of Vermont