NCT01118351

Sunitinib Malate in Treating Patients With Recurrent Transitional Cell Bladder Cancer

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Bladder Cancer
• Transitional Cell Carcinoma of the Bladder

Interventions

Type	Name	Description
DRUG	sunitinib malate	Given orally
OTHER	immunohistochemistry staining method	Correlative studies
OTHER	TdT-mediated dUTP nick end labeling assay	Correlative studies
OTHER	light microscopy	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2008-10-01
• Primary completion: 2012-07-01
• Completion: 2015-09-01
• First posted: 2010-05-06
• Last updated: 2019-05-01
• Results posted: 2019-04-04

Locations

2 sites across 1 country: United States