Clinical trial NCT00462488: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urinary Bladder Cancer
Bladder Cancer
Bladder Neoplasms
Bladder Tumors
Lead sponsor: Sesen Bio, Inc.
Sponsor class: INDUSTRY
First posted: 2007-04-19
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Other

* 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

Primary outcomes:
measure: Treatment Schedule A: 12-Week Efficacy, Treatment Schedule B: 13-Week Efficacy
timeFrame: 12 or 13 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Southeastern Research Group, Inc.
state: Florida
city: Baltimore
country: United States
facility: Johns Hopkins Medical Institutions
state: Maryland
city: Lawrenceville
country: United States
facility: Lawrenceville Urology
state: New Jersey
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Springfield
country: United States
facility: Oregon Urology Institute Research
state: Oregon
city: Myrtle Beach
country: United States
facility: Grand Strand Urology
state: South Carolina
city: Corpus Christi
country: United States
facility: Corpus Christi Urology Group, LLP
state: Texas
city: Newport News
country: United States
facility: Urology of Virginia
state: Virginia
city: Surrey
country: Canada
facility: Andreou Research
state: British Columbia
city: Victoria
country: Canada
facility: Can-Med Clinical Research Inc.
state: British Columbia
city: Barrie
country: Canada
facility: The Male/Female Health and Research Centre, Royal Court Medical Centre
state: Ontario
city: Burlington
country: Canada
facility: Urology Resource Centre
state: Ontario
city: Hamilton
country: Canada
facility: McMaster University, Institute of Urology at Saint Joseph's Hospital
state: Ontario
city: Kingston
country: Canada
facility: Centre for Applied Urological Research
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Oakville
country: Canada
facility: The Fe/Male Health Centre
state: Ontario
city: Owen Sound
country: Canada
facility: Todd Webster, M.D.
state: Ontario
city: Scarborough
country: Canada
facility: The Scarborough Hospital
state: Ontario
city: Toronto
country: Canada
facility: University of Toronto, Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke, Hopital Fleuimont
state: Quebec
Study officials:
affiliation: Sesen Bio, Inc.
name: Wendy Chapman
role: STUDY_DIRECTOR
References:
citation: Kowalski M, Guindon J, Brazas L, Moore C, Entwistle J, Cizeau J, Jewett MA, MacDonald GC. A phase II study of oportuzumab monatox: an immunotoxin therapy for patients with noninvasive urothelial carcinoma in situ previously treated with bacillus Calmette-Guerin. J Urol. 2012 Nov;188(5):1712-8. doi: 10.1016/j.juro.2012.07.020. Epub 2012 Sep 19.