Tinzaparin in Treating Patients With Metastatic Kidney Cancer That Cannot Be Removed By Surgery
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|ClinicalTrials.gov Identifier: NCT00293501|
Recruitment Status : Unknown
Verified February 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : February 17, 2006
Last Update Posted : November 6, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer||Drug: tinzaparin sodium||Phase 1 Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Trial of Tinzaparin (Innohep), a Low Molecular Weight Heparin (LMWH) for Treatment of Advanced Renal Cell Carcinoma|
|Study Start Date :||December 2005|
|Estimated Primary Completion Date :||February 2007|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|