Study of Vicinium for Treating Patients With Non-Invasive Urothelial Carcinoma In Situ
Condition: Urinary Bladder Cancer; Bladder Cancer; Bladder Neoplasms; Bladder Tumors
MeSH terms: Urinary Bladder Neoplasms; Carcinoma, Transitional Cell; Carcinoma in Situ
Intervention: Vicinium
Intervention description: Intravesical administration of Vicinium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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).
    

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