A New Experimental Therapy to Treat Your Bladder Cancer (Viventia VB4-845-02-IIIA)
Technical Title: An Open Label, Multicenter, Phase 3 Study to Evaluate the Efficacy and Tolerability of Intravesical Vicinium™ in Subjects with Non Muscle-Invasive Carcinoma in Situ (CIS) and /or High-Grade Papillary Disease of the Bladder Previously Treated with Bacillus Calmette-Guérin (BCG)
Disease Type: Non Muscle-invasive Carcinoma in Situ and/or High-grade Papillary Disease of the Bladder, previously treated with BCG
This study is designed to obtain information on the safety and the effectiveness of an experimental drug called Vicinium to treat Non Muscle-Invasive Carcinoma in Situ (CIS) and/or High-Grade Papillary Disease of the Bladder.
Vicinium is placed directly into your bladder though a catheter. Delivering a drug this way is called an instillation.
Research Procedures (not a complete list):
The study drug is given in two phases. The first phase is called the Induction phase. During this phase, you will receive Vicinium twice a week for 6 weeks, then once a week for 6 weeks for a total of 12 weeks (18 doses). You will be expected to stay in the clinic for about 3 hours at each visit. You will need to complete blood and urine tests, physical exams, and EKGs according to the study schedule. At Week 13, you will undergo a cystoscopy and biopsies of areas of your bladder that are suspicious for cancer to see if your cancer responded to treatment.
If the biopsies show that your cancer is responding to treatment, you may continue on to the Maintenance phase. During this phase, you will receive a dose of Vicinium once every other week for approximately 24 months (2 years). You will need to complete blood and urine tests and physical exams according to the study schedule. Every 13 weeks, you will be evaluated to see if your disease continues to respond to treatment.
Eligibility Criteria (Not a complete list):
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