RecruitMe Clinical Trial

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-Gurin (BCG)
A study for patients with bladder cancer using study drug Vincinum
Sponsor:Viventia
Enrolling:Male and Female Patients
Age Range:Between 18 and 99 years old
IRB Number:AAAQ5802
U.S. Government ID:NCT02449239
Contact: Joel DeCastro: 212-305-0114 / gjd16@cumc.columbia.edu
Additional Study Information:

This study is designed to obtain information on the safety and the effectiveness of an experimental drug called Vicinium when it is given to human subject(s)/participant(s) with bladder cancer that has not spread to the muscle of the bladder. Vicinium is part of an antibody connected to a protein that can kill cells. The protein is a modified pseudomonas exotoxin A. Vicinium is designed to attach to cells that have a different protein called EpCAM on the outside of the cell. After attaching to a cell, the modified pseudomonas exotoxin A can be released in the cell causing the cell to die. It is thought that almost all bladder cancer cells has EpCAM on the outside. About 70 medical centers in North America (United States and Canada) are expected to participate in this study. About 134 subject(s)/participant(s) will participate in the study. Male and non-pregnant/non-lactating females age 18 years or older that meet all study requirements will be able to participate in this study. The expected treatment length of this study is up to 24 months.

This study is closed
Investigator
Joel DeCastro, MD
You may be eligible for this study

Place Holder




Who Can I Contact?
For more information, please contact:
Joel DeCastro
Email: gjd16@cumc.columbia.edu
Phone: 212-305-0114