Sunitinib Malate in Treating Patients With Recurrent Transitional Cell Bladder Cancer

Phase 2

Terminated

Conditions: Transitional Cell Carcinoma of the Bladder
Recurrent Bladder Cancer

Interventions: Drug: sunitinib malate
Other: immunohistochemistry staining method
Other: TdT-mediated dUTP nick end labeling assay
Other: light microscopy
Other: laboratory biomarker analysis

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Arm I	immunohistochemistry staining method	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.
Arm I	sunitinib malate	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.
Arm I	TdT-mediated dUTP nick end labeling assay	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.
Arm I	laboratory biomarker analysis	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.
Arm I	light microscopy	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.

Primary Outcome Measures

Name	Time	Method
Complete Response Rate	At 12 months after completion of treatment	Number of patients with complete response defined as negative cystoscopy with negative biopsy and no evidence of cancer on urine cytology 12 months after treatment with sunitinib.

Secondary Outcome Measures

Name	Time	Method
Recurrence-free Survival	at 12 months after completion of treatment	Time from registration (up to 28 days prior to treatment) to the first documentation of recurrence assessed up to 12 months after completion of treatment (up to 12 weeks). Time period can be up to 16 months from time of registration.
Progression-free Survival	at 12 months after completion of treatment	Number of patients last known to be alive and not to have progressed are censored at the last day of contact. Progression is defined as: Biopsy proven muscle invasive disease ≥ Stage T2 or death due to any cause.
Overall Survival	at 12 months after completion of treatment	Number of patients still alive from date of registration to date of death due to any cause.
Toxicity Assessed, Graded, and Tabulated Using CTCAE Version 3.0	at 12 months after completion of treatment	Number of participants that experienced adverse events.

Locations (2): CCF-Fairview Hospital
🇺🇸
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
🇺🇸
Cleveland, Ohio, United States