Tinzaparin in Treating Patients With Metastatic Kidney Cancer That Cannot Be Removed By Surgery
This trial is active, not recruiting.
|Phase||phase 1/phase 2|
|Sponsor||University of Vermont|
|Collaborator||National Cancer Institute (NCI)|
|Start date||December 2005|
|End date||February 2007|
|Trial size||35 participants|
|Trial identifier||NCT00293501, CDR0000459794, VCC-0403, VCC-05-040|
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 in treating patients with metastatic kidney cancer that cannot be removed by surgery.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Chicago, IL||University of Chicago Cancer Research Center||no longer recruiting|
|Lebanon, NH||Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center||no longer recruiting|
|Burlington, VT||Vermont Cancer Center at University of Vermont||no longer recruiting|
Blood markers or coagulation as measured by plasma prothrombin F1.2, thrombin-antithrombin complexes, and D-dimers at 2 weeks, 2 months and 6 months
Blood markers of angiogenesis as measured by serum vascular endothelial growth factor (VEGF) and basic fibroblast growth factor (bFGF) at 2 weeks, 2 months, and 6 months
Venous thromboembolism as measured by clinical evaluation at 6 months
Progression free survival as measured by clinical evaluation at 4 months
Male or female participants at least 18 years old.
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
|Official title||A Phase I/II Trial of Tinzaparin (Innohep), a Low Molecular Weight Heparin (LMWH) for Treatment of Advanced Renal Cell Carcinoma|
|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) from baseline to 2 weeks and at nadir or disease progression in patients with unresectable metastatic renal cell carcinoma (RCC). Secondary - Determine the effect of tinzaparin sodium treatment on circulating angiogenesis markers, including vascular endothelial growth factor (VEGF) and basic fibroblast growth factor (bFGF). - Determine the proportion of patients developing venous thromboembolism and hemorrhage. - Determine the tolerability of tinzaparin sodium treatment for up to 6 months in these patients. - Establish the feasibility of undertaking a multicenter renal cell carcinoma trial with specialized coagulation test collection, shipping, and processing. - Obtain more accurate and specific mean, median, and variability in biomarker data in advanced RCC patients treated with tinzaparin sodium for purposes of planning larger future trials. - Estimate the progression-free survival at 4 months in patients treated with tinzaparin sodium. - Correlate progression-free survival with changes in markers of coagulation activation or angiogenesis. - Correlate the anticoagulant activity of tinzaparin sodium (anti-Xa activity) with change in coagulation markers, angiogenesis markers, and progression-free survival. OUTLINE: This is an open-label, pilot, multicenter study. Patients receive a treatment dose of tinzaparin sodium subcutaneously (SC) once daily for 14 days followed by a prophylactic dose of tinzaparin sodium SC once daily for up to 6 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.|
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