NCT00293501

Tinzaparin in Treating Patients With Metastatic Kidney Cancer That Cannot Be Removed By Surgery

A Phase I/II Trial of Tinzaparin (Innohep), a Low Molecular Weight Heparin (LMWH) for Treatment of Advanced Renal Cell Carcinoma

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: University of Vermont · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Cancer

Interventions

Type	Name	Description
DRUG	tinzaparin sodium

Timeline

• Start date: 2005-12-01
• Primary completion: 2007-02-01
• First posted: 2006-02-17
• Last updated: 2013-11-06

Locations

3 sites across 1 country: United States