Kidney Cancer Clinical Trial
Official title:
A Phase I/II Trial of Tinzaparin (Innohep), a Low Molecular Weight Heparin (LMWH) for Treatment of Advanced Renal Cell Carcinoma
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.
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.
;
Masking: Open Label, Primary Purpose: Treatment
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