Bacillus Calmette-Guerin Followed by Sunitinib for the Treatment of High Risk Non-muscle Invasive Lower Urinary Tract Urothelial Carcinoma (Sutent)
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|ClinicalTrials.gov Identifier: NCT00794950|
Recruitment Status : Completed
First Posted : November 21, 2008
Results First Posted : September 23, 2019
Last Update Posted : September 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Urinary Tract Urothelial Carcinoma||Drug: Sunitinib||Phase 2|
Despite a complete response of 45-55% in patients with non-muscle invasive urothelial carcinoma involving the lower urinary tract at 3 months, many patients suffer from multiple recurrences and progression in up to 1/3 of patients. While radical cystectomy is an effective local therapy for patients with high risk non-invasive disease, roughly 15% of patients will still develop progression. More importantly, the morbidity of radical cystectomy as described above represents a barrier to treatment in some individuals. Thus, there is a real need to identify newer therapies that reduce morbidity and improve outcomes in patients with non-invasive urothelial cancer. While multiple drug regimens have been the standard for many forms of cancer including invasive bladder cancer, few reports exist on multidrug regimens for non-invasive bladder cancer.
The fundamentally agreed upon mechanism of action of BCG intravesical therapy for superficial bladder cancer is the generation of a non-specific immune response with the expression of cytokines by inflammatory cells resulting in tumor death. Cytokines produced by BCG therapy such as IFNα may block vascular endothelial growth factor (VEGF) which is expressed in superficial and invasive bladder cancer and may provide a mechanism for disease progression.
Sunitinib is an oral tyrosine kinase inhibitor that blocks VEGF. Recent reports demonstrate clinical response in patients with metastatic bladder cancer treated with sunitinib after recurrence following standard chemotherapeutic regimens. The addition of sunitinib following BCG in order to consolidate VEGF inhibition may result in superior 3 month complete response rates. We know that patients who have a complete response to BCG at 3 months have improved disease.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Intravesical Bacillus Calmette-Guerin Followed by Sunitinib for the Treatment of High Risk Non-muscle Invasive Lower Urinary Tract Urothelial Carcinoma|
|Actual Study Start Date :||January 2009|
|Actual Primary Completion Date :||August 22, 2016|
|Actual Study Completion Date :||August 22, 2016|
Experimental: Sunitinib treatment
Intravesical BCG (81 mg Theracys BCG in 50 ml normal saline) once weekly for 6 weeks within 6 weeks of bladder biopsy confirming high risk non-muscle invasive urothelial carcinoma.
Patients are treated with a 6-week induction course of intravesical bacillus Calmette-Guerin (BCG) followed by a 2 week rest period and 4 week course of oral Sunitinib.
Patients will receive intravesical BCG (81 mg Theracys BCG in 50 ml normal saline) once weekly for 6 weeks within 6 weeks of bladder biopsy confirming high risk non-muscle invasive urothelial carcinoma. Two weeks after completion of BCG, patients will receive Sunitinib (50 mg daily) continuously for 28 days followed by a two week rest period. Patients will be reassessed with transurethral resection and urine cytology. Those with residual/recurrent disease will receive a second course identical to the initial protocol. Those with a complete response following initial or second treatment will be placed on maintenance BCG (3 week course every 6 months for 2 years). Those failing (progression, intolerance) initial/secondary treatments will be offered alternative therapy.
Other Name: Sutent
- Number of Participants With Complete Response at 3 Months [ Time Frame: 14 weeks ]Complete response is defined as no evidence of cancer on bladder biopsy or on a urine test that looks for cancer cells (cytology)
- Percentage of Participants Who Experienced a Complete Response at 6 Months, Following Study Regimen. [ Time Frame: 28 weeks ]Complete response is defined as no evidence of cancer on bladder biopsy or on a urine test that looks for cancer cells (cytology)
- Recurrence-free Survival at 2 Years in Patients With Intact Bladder. [ Time Frame: 2 years ]
- Number of Participants With Toxicity Related to Treatment With BCG Followed by Sunitinib [ Time Frame: 26 months ]
Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was used to characterize the toxicity: Toxic events are listed by name, body system and grade.
Note: to fit within character length constraints, "3" below means Grade 3; and S & S means Skin and Subcutaneous system.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00794950
|United States, Maryland|
|Mark P. Schoenberg, MD|
|Baltimore, Maryland, United States, 21287-2101|
|United States, Michigan|
|Alon Weizer, MD|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Alon Weizer, MD||University of Michigan|