Spots Global Cancer Trial Database for Study of Vicinium for Treating Patients With Non-Invasive Urothelial Carcinoma In Situ
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Trial Identification
Brief Title: Study of Vicinium for Treating Patients With Non-Invasive Urothelial Carcinoma In Situ
Official Title: Phase II Study to Evaluate the Efficacy and Tolerability of Intravesical Vicinium™ in Patients With Non-Invasive Urothelial Carcinoma in Situ (CIS) Previously Treated With Bacille Calmette-Guérin (BCG)
Study ID: NCT00462488
Interventions
Study Description
Brief Summary: 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).
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Southeastern Research Group, Inc., Tallahassee, Florida, United States
Johns Hopkins Medical Institutions, Baltimore, Maryland, United States
Lawrenceville Urology, Lawrenceville, New Jersey, United States
Duke University Medical Center, Durham, North Carolina, United States
Oregon Urology Institute Research, Springfield, Oregon, United States
Grand Strand Urology, Myrtle Beach, South Carolina, United States
Corpus Christi Urology Group, LLP, Corpus Christi, Texas, United States
Urology of Virginia, Newport News, Virginia, United States
Andreou Research, Surrey, British Columbia, Canada
Can-Med Clinical Research Inc., Victoria, British Columbia, Canada
The Male/Female Health and Research Centre, Royal Court Medical Centre, Barrie, Ontario, Canada
Urology Resource Centre, Burlington, Ontario, Canada
McMaster University, Institute of Urology at Saint Joseph's Hospital, Hamilton, Ontario, Canada
Centre for Applied Urological Research, Kingston, Ontario, Canada
London Health Sciences Centre, London, Ontario, Canada
The Fe/Male Health Centre, Oakville, Ontario, Canada
Todd Webster, M.D., Owen Sound, Ontario, Canada
The Scarborough Hospital, Scarborough, Ontario, Canada
University of Toronto, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Centre Hospitalier Universitaire de Sherbrooke, Hopital Fleuimont, Sherbrooke, Quebec, Canada
Contact Details
Name: Wendy Chapman
Affiliation: Sesen Bio, Inc.
Role: STUDY_DIRECTOR
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