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

Completed · Phase 2

Conditions studied: Urinary Bladder Cancer, Bladder Cancer, Bladder Neoplasms, Bladder Tumors

In brief

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).

Key facts

Study ID

NCT00462488

Run by

Sesen Bio, Inc.

People needed

46

Starts

2007-03-01

Expected to finish

2009-10-01

Last updated by the study team

2020-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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 Village, 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

Full record on ClinicalTrials.gov

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