Spots Global Cancer Trial Database for Sunitinib Malate in Treating Patients With Recurrent Transitional Cell Bladder Cancer

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Trial Identification

Brief Title: Sunitinib Malate in Treating Patients With Recurrent Transitional Cell Bladder Cancer

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

Study ID: NCT01118351

Conditions

Recurrent Bladder Cancer

Transitional Cell Carcinoma of the Bladder

Interventions

sunitinib malate

immunohistochemistry staining method

TdT-mediated dUTP nick end labeling assay

light microscopy

laboratory biomarker analysis

Study Description

Brief Summary: 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.

Detailed Description: 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.