Tinzaparin in Treating Patients With Metastatic Kidney Cancer That Cannot Be Removed By Surgery
- Conditions
- Kidney Cancer
- Registration Number
- NCT00293501
- Lead Sponsor
- University of Vermont
- 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 in treating patients with metastatic kidney cancer that cannot be removed by surgery.
- 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) 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 35
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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 Progression free survival as measured by clinical evaluation at 4 months Venous thromboembolism as measured by clinical evaluation at 6 months
Trial Locations
- Locations (3)
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Vermont Cancer Center at University of Vermont
🇺🇸Burlington, Vermont, United States