Transitional Cell Carcinoma of the Bladder Clinical Trial
Official title:
Phase II Single Arm, Open Label, Single Institution Study of Continuous Sunitinib (Sutent) in Patients With High-Risk (BCG-Refractory) Superficial Transitional Cell Carcinoma (TCC) of the Bladder
RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the
enzymes needed for cell growth or by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sunitinib malate works in treating patients
with recurrent transitional cell bladder cancer.
PRIMARY OBJECTIVES:
I. To determine the clinical efficacy of oral sunitinib (Sutent) given continuously for a
maximum of 12 weeks, with respect to complete response rates at 12 months after completion of
treatment in patients with high-risk superficial bladder cancer who have failed previous
intravesical BCG.
SECONDARY OBJECTIVES:
I. To assess the impact of sunitinib treatment in recurrence-free survival, progression-free
survival, and overall survival in patients with high-risk superficial TCC of the bladder who
have failed previous intravesical BCG.
II. To evaluate the safety and tolerability of sunitinib (Sutent) administered in patients
with high-risk superficial TCC of the bladder who have failed previous intravesical BCG.
TERTIARY OBJECTIVES:
I. To assess pre-treatment tissue baseline angiogenic markers and to evaluate the magnitude
of the difference among these variables with post-treatment tumor tissue after treatment with
sunitinib (Sutent).
II. To evaluate the effects of Sunitinib (Sutent) on immunosuppressive regulatory T cells
(Tregs).
III. To determine the presence of circulating tumor cells in superficial BCG-refractory TCC
patients.
OUTLINE:
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 28
days for 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
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