Vicinium Treatment for Subjects With Non-muscle Invasive Bladder Cancer Previously Treated With BCG

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 16-000544
    NCT ID: NCT02449239
    Sponsor Protocol Number: VB4-845-02-IIIA

About this study

Because of the high risk for development of muscle invasive disease, cystectomy is recommended for CIS, high-grade Ta and T1 patients who experience disease recurrence following intravesical therapy. Vicinium is an experimental agent that may provide an alternative to cystectomy

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Histologically-confirmed non muscle-invasive bladder cancer with CIS, high grade Ta or any grade T1 papillary disease or CIS plus papillary disease following adequate BCG treatment
  • CIS, Ta or T1 disease is documented as unresponsive to (i.e., not intolerant to) adequate BCG therapy
    • Adequate BCG therapy is defined as at least 7 instillations of BCG over 2 cycles (1 induction course of at least 5 doses over 6 weeks + 1 maintenance cycle of at least 2 doses over 6 weeks, or up to 2 induction courses of BCG with or without interferon)
  • Male or non-pregnant, non-lactating female
  • Females of childbearing potential and all males with partners of childbearing age only if they agree to use highly effective contraceptive techniques or abstinence during the 24-month study period
  • Has had bladder biopsy mapping the location of the tumors and quantifying the affected area of the bladder within 8 weeks before study drug administration
  • Has life expectancy of at least 4 years
  • Has adequate organ function, as defined by
    • Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 x upper limit of normal (ULN)
    • Total serum bilirubin ≤1.5 x ULN (CTCAE grade ≤1)
    • Serum creatinine ≤2.0 x ULN
      • A serum creatinine >1 x ULN must also have creatinine clearance ≥50 mL/min
    • Hemoglobin ≥8.0 g/dL
      • Subjects receiving therapeutic erythropoietin preparations (i.e., epoetin alfa, darbepoetin alfa) are eligible to enroll
    • Absolute neutrophil count ≥1500 x 109/L
    • Platelets ≥75,000 x 109/L
  • Ability to understand and sign an Independent Ethics Committee or Institutional Review Board approved informed consent document

Exclusion Criteria

  • Is pregnant or breastfeeding
  • Evidence of urethral or upper tract transitional cell carcinoma (TCC) by biopsy or upper tract radiological imaging 
  • Evidence of higher stage disease by pelvic imaging within the past 2 years
  • Has hydronephrosis, except for where hydronephrosis has been longstanding (i.e., predates the diagnosis of the CIS, Ta or T1 by more than 2 years) and diagnostic evaluation at screening shows no evidence of tumor
  • Has had any intravesicular or other chemotherapy treatment within 2 weeks or any investigational agent within 4 weeks prior to the initial dose of study drug
  • Current severe urinary tract infection 
  • History of recurrent severe bacterial cystitis
  • Has an active, uncontrolled impairment of the urogenital, renal, hepatobiliary, cardiovascular, gastrointestinal, neurologic or hematopoietic systems which, in the opinion of the Investigator, would predispose to the development of complications from the administration of intravesical therapy and/or general anesthesia
  • History of other primary malignancy (other than squamous or basal cell skin cancers) that will require concomitant cancer therapy during the 24 months of the study
  • A QTc interval of >450 msec for males or > 470 msec for females at the screening ECG
  • Cannot, in the opinion of the Investigator, tolerate intravesical administration or intravesical surgical manipulation

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Erik Castle, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

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CLS-20232529

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