Tinzaparin in Treating Patients With Metastatic Kidney Cancer That Cannot Be Removed By Surgery
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Trial of Tinzaparin (Innohep), a Low Molecular Weight Heparin (LMWH) for Treatment of Advanced Renal Cell Carcinoma|
- 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 [ Designated as safety issue: No ]
- 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 [ Designated as safety issue: No ]
- Venous thromboembolism as measured by clinical evaluation at 6 months [ Designated as safety issue: No ]
- Progression free survival as measured by clinical evaluation at 4 months [ Designated as safety issue: No ]
|Study Start Date:||December 2005|
|Estimated Primary Completion Date:||February 2007 (Final data collection date for primary outcome measure)|
- 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).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00293501
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|United States, New Hampshire|
|Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756-0002|
|United States, Vermont|
|Vermont Cancer Center at University of Vermont|
|Burlington, Vermont, United States, 05405-0110|
|Study Chair:||Deborah L. Ornstein, MD||Yale University|