The purpose of this study is to evaluate the efficacy and tolerability of Vicinium when administered as a monotherapy intravesical instillation in patients with non-invasive urothelial carcinoma in situ (CIS) who failed previous treatment with Bacille Calmette Guérin (BCG).
A phase II study was performed to assess the efficacy and tolerability of intravesical Vicinium in patients with urothelial carcinoma in situ of the bladder. Bacillus Calmette-Guérin treatment had previously failed in all patients. A total of 46 patients were treated with Vicinium with half being administered 30mg/dose once per week for 6 weeks (cohort 1) and the other half (cohort 2) the same dose but administered once per week for 12 consecutive weeks. Disease assessments consisting of urine cytology, cystoscopy and, if indicated, biopsy were performed at 3 month intervals. Patients that were disease-free at the assessment time point were allowed to continue treatment in the maintenance phase which consisted of three weekly doses, followed by 9 weeks of no treatment. As long as the patient remained disease-free, treatment continued for a total of one year.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Intravesical administration of Vicinium
Southeastern Research Group, Inc.
Tallahassee, Florida, United States
Treatment Schedule A: 12-Week Efficacy, Treatment Schedule B: 13-Week Efficacy
Complete response rate in subjects with carcinoma in situ (CIS) non-muscle invasive bladder cancer (NMIBC) following the induction phase (3-month evaluation point) of Vicinium treatment
Time frame: 12 or 13 weeks
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