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Study of Vicinium for Treating Patients With Non-Invasive Urothelial Carcinoma In Situ

This study has been completed.
Information provided by (Responsible Party):
Viventia Bio Identifier:
First received: April 17, 2007
Last updated: May 12, 2015
Last verified: May 2015
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).

Condition Intervention Phase
Urinary Bladder Cancer
Bladder Cancer
Bladder Neoplasms
Bladder Tumors
Drug: Vicinium
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by Viventia Bio:

Primary Outcome Measures:
  • Treatment Schedule A: 12-Week Efficacy, Treatment Schedule B: 13-Week Efficacy [ Time Frame: 12 or 13 weeks ]

Enrollment: 46
Study Start Date: March 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment Schedule A -

Induction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 6 weeks. If free of disease at 12 weeks after the first instillation, the subject enters Maintenance dosing in which 30 mg of Vicinium is administered once per week for 3 weeks followed by 9 weeks of no therapy.

If the subject had histologically confirmed disease that is stage <T2, they repeat the Induction phase dosing. If the subject is free of disease, the subject enters the maintenance dosing phase of every 12 weeks (3 weeks of therapy followed by 9 weeks of no therapy until disease recurrence is confirmed by positive biopsy or up to a maximum of Week 51 (end-of-study [EOS]).

Drug: Vicinium
Intravesical administration of Vicinium
Other Name: VB4-845
Active Comparator: Treatment Schedule B

Induction Phase is a single intravesical dose of Vicinium at 30 mg in 40 mL PBS once per week for 12 weeks followed by 1 week of no therapy.

If 13 weeks after the first instillation of Vicinium the subject is free of disease, they have a break from therapy before entering Maintenance dosing in which 30 mg of Vicinium is administered once weekly for 3 weeks followed by 9 weeks of no therapy. If the subject is free of disease, additional maintenance cycle(s) are repeated every 12 weeks (3 weeks of therapy followed by 9 weeks of no therapy until disease recurrence is confirmed by positive biopsy or up to a maximum of Week 57 (EOS).

Drug: Vicinium
Intravesical administration of Vicinium
Other Name: VB4-845

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. Vicinium was well tolerated in both cohorts as all patients completed treatment on schedule. A complete response to Vicinium was seen in 9 of 22 patients (41%) in cohort 1 and 9 of 23 (39%) in cohort 2 at the 3-month evaluation. A total of 20 patients (44%) achieved a complete response. Two other patients without carcinoma in situ who achieved a complete response were not included in the study due to the development of non-invasive papillary (Ta) disease. Median time to recurrence in patients who achieved a complete response was 274 and 408 days in cohorts 1 and 2, respectively. Overall 7 patients (16%) remained disease free. Post-study assessment demonstrated that these patients were still disease free at last follow-up (18 to 25 months). The most common adverse events were mild to moderate reversible bladder symptoms.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Disease Characteristics

  • The patient must be male or female 18 years of age or older.
  • The patient must have histologically-confirmed Transitional Cell Carcinoma (TCC) of the bladder.
  • The patient must have histologically-confirmed carcinoma in situ (CIS), with or without non-invasive papillary disease
  • The patient must have immunohistochemically-confirmed EpCAM positive disease.
  • The patient must have a life expectancy of at least 12 months.

Prior/Concurrent Therapy

  • The patient must have, within the last 24 months, failed to respond to at least 1 cycle of treatment with BCG (with or without interferon) or be intolerant to BCG treatment.
  • The patient must have had a transurethral resection of the bladder tumour (TURBT) mapping the location of tumour and quantifying the area of bladder affected.
  • The patient must have documented residual CIS (i.e. unresectable disease) prior to study drug administration.

Patient Characteristics

The patient must have adequate organ function, as defined by the clinical trial protocol


  • The patient must have the ability to understand and sign an Independent Ethics Committee or Institutional Review Board (IEC/IRB)- approved informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment and is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

  • The patient has evidence of urethral or upper tract transitional cell carcinoma (TCC) by biopsy or upper tract radiological imaging (i.e. intravenous pyelogram, computed tomography (CT) urogram, or retrograde pyelogram) within the past 2 years
  • The patient has hydronephrosis
  • The patient has had prior intravesical chemotherapy or investigational or anti-cancer treatments within the last 2 months, inclusive of single-dose adjuvant intravesical chemotherapy immediately post-TURBT
  • The patient has existing severe urinary tract infection or recurrent severe bacterial cystitis
  • The patient has active, uncontrolled impairment of the renal, hepatobiliary, cardiovascular, gastrointestinal, urogenital, neurologic or hematopoietic systems which, in the opinion of the investigator, would predispose the patient to the development of complications from the administration of intravesical therapy and/or general anesthesia
  • Any patient who, in the opinion of the investigator, cannot tolerate intravesical administration or intravesical surgical manipulation (cystoscopy, biopsy) due to the presence of concomitant serious illness (i.e. uncontrolled cardiac or respiratory disorders)
  • The patient is pregnant or breast feeding
  • Women of reproductive age (who are not either medically or surgically incapable or bearing children) and all men may not participate unless agreeing to use double barrier contraception, or commit to abstinence during the period of therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00462488

United States, Florida
Southeastern Research Group, Inc.
Tallahassee, Florida, United States, 32308
United States, Maryland
Johns Hopkins Medical Institutions
Baltimore, Maryland, United States, 21287
United States, New Jersey
Lawrenceville Urology
Lawrenceville, New Jersey, United States, 08648
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Oregon
Oregon Urology Institute Research
Springfield, Oregon, United States, 97477
United States, South Carolina
Grand Strand Urology
Myrtle Beach, South Carolina, United States, 29572
United States, Texas
Corpus Christi Urology Group, LLP
Corpus Christi, Texas, United States, 78404
United States, Virginia
Urology of Virginia
Newport News, Virginia, United States, 23606
Canada, British Columbia
Andreou Research
Surrey, British Columbia, Canada, V3V 1N1
Can-Med Clinical Research Inc.
Victoria, British Columbia, Canada, V8T 5G9
Canada, Ontario
The Male/Female Health and Research Centre, Royal Court Medical Centre
Barrie, Ontario, Canada, L4M 7G1
Urology Resource Centre
Burlington, Ontario, Canada, L7S 1V2
McMaster University, Institute of Urology at Saint Joseph's Hospital
Hamilton, Ontario, Canada, L8N 4A6
Centre for Applied Urological Research
Kingston, Ontario, Canada, K7L 2V7
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5
The Fe/Male Health Centre
Oakville, Ontario, Canada, L6H 3P1
Todd Webster, M.D.
Owen Sound, Ontario, Canada, N4K 2J1
The Scarborough Hospital
Scarborough, Ontario, Canada, M1P 2T7
University of Toronto, Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Centre Hospitalier Universitaire de Sherbrooke, Hopital Fleuimont
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Viventia Bio
Study Director: Wendy Chapman Viventia Bio
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Viventia Bio Identifier: NCT00462488     History of Changes
Other Study ID Numbers: VB4-845-02-IIA
Study First Received: April 17, 2007
Last Updated: May 12, 2015

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Carcinoma in Situ
Carcinoma, Transitional Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type processed this record on April 26, 2017