Clear Cell Renal Cell Carcinoma Clinical Trial
Official title:
Phase II Study of MLN518 in Patients With Metastatic Clear Cell Renal Cell Carcinoma
This phase II trial is studying how well tandutinib works in treating patients who have undergone surgery for metastatic kidney cancer. Tandutinib may stop the growth of kidney cancer by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving tandutinib after surgery may kill any tumor cells that remain after surgery.
PRIMARY OBJECTIVES:
I. To determine the overall efficacy of MLN518 in patients with metastatic clear cell renal
carcinoma.
SECONDARY OBJECTIVES:
I. To evaluate the effect of MLN518 on progression-free survival and overall survival in
patients with metastatic clear cell renal carcinoma.
II. To evaluate the toxicity of MLN518 in patients with metastatic clear cell renal
carcinoma.
III. To evaluate the effects of MLN518 on serum VEGF-A, VEGF-R2, PIGF, and PDGF levels of
patients with metastatic renal cell carcinoma receiving MLN518.
IV. To determine the VHL gene status, methylation, and pVHL in archived material from the
primary nephrectomy specimen of patients receiving MLN518.
V. To evaluate tumor blood flow and vessel permeability based on functional imaging with
dynamic contrast enhanced magnetic resonance imaging (dceMRI) in metastatic renal cell
carcinoma patients treated with MLN518.
OUTLINE: This is an open-label, nonrandomized study.
Patients receive oral tandutinib twice daily on days 1-28. Treatment repeats every 28 days in
the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 4 weeks.
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