Trial of Intravesical Measles Virotherapy in Patients With Bladder Cancer Who Are Undergoing Radical Cystectomy

Overview

  • Study type

    Interventional
  • Study phase

    I
  • 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
    • Jacksonville, Florida: 17-004167
    • Rochester, Minnesota: 17-004167
    NCT ID: NCT03171493
    Sponsor Protocol Number: VYR-MV1-102

About this study

This is a Phase 1 study designed to test the tolerability and feasibility of intravesical therapy with an attenuated Measles virus (MV-NIS) in patients with urothelial carcinoma who are undergoing radical cystectomy but are ineligible or do not desire neoadjuvant chemotherapy.

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:

  • Age ≥ 18 years.
  • Diagnosis of UC of the bladder, with:
    • histologic confirmation of the primary UC pathology;
    • indication for RC;
    • ineligibility for platinum-based neoadjuvant chemotherapy. This may be due to (i) patients not being indicated for neoadjuvant chemotherapy due to noninvasive disease; (ii) not eligible for neoadjuvant chemotherapy due to safety concerns, contraindications, or comorbidities OR (iii) patients refused neoadjuvant chemotherapy.
  • ECOG Performance Status (PS) 0 or 1.
  • Ability to provide informed consent.
  • Willingness to comply with all required protocol procedures including providing biologic specimens and returning to the clinical study site for follow up visits.
  • Performance status sufficient to undergo RC (in the opinion of the enrolling urologist).
  • The following laboratory values obtained ≤ 14 days prior to study day 1:
    • ANC ≥1500/mm3;
    • Platelets ≥100,000/mm3;
    • HgB >9.0 g/dL;
    • Total bilirubin ≤ institutional upper limit of normal (ULN);
    • SGOT (AST) ≤1.5 x ULN;
    • Creatinine clearance ≥ 30 ml/min.
  • Must be willing to implement contraception throughout the study and for 8 weeks after intravesical administration of MV-NIS.

Exclusion Criteria:

 

  • Variant UC pathology including but not limited to micropapillary, signet ring, sarcomatoid, UC with squamous differentiation and clear cell variants.
  • Patients with any other prior malignancy are not allowed except for the following:
    • History of or concurrent non-invasive UC involving a portion of urinary tract outside of the bladder;
    • Adequately treated basal cell or squamous cell skin cancer;
    • In situ cervical cancer;
    • Adequately treated Stage I or II cancer from which the patient is currently in complete remission or other cancer from which the patient has been disease-free for 2 years.
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
  • Any of the following prior therapies:
    • Chemotherapy ≤ 3 weeks prior to study day 1;
    • Biologic therapy ≤ 4 weeks prior to study day 1;
    • Radiation therapy ≤ 3 weeks prior to study day 1;
    • Investigational therapy ≤ 4 weeks prior to study day 1.
  • Failure to fully recover from acute, reversible effects defined as ≤ grade 1 CTCAE v.4.03 of prior systemic therapy regardless of interval since last treatment.
  • Other concurrent investigational therapy (utilized for a non-FDA-approved indication and in the context of a research investigation).
  • Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
    • Pregnant women;
    • Nursing women;
    • Men or women of childbearing potential who are unwilling to employ adequate contraception during treatment and 8 weeks after intravesical administration of MV-NIS.
  • Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immuno-suppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • History of organ transplantation.
  • Requiring blood product support.
  • Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA), or human immunodeficiency virus (HIV1 or 2) indicating acute or chronic infection.
  • Active infection (any grade) ≤5 days prior to study day 1.
  • Active TB infection.
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  • Current exposure to household contacts ≤15 months old or household contact with known immunodeficiency.
  • Unwillingness to avoid household contacts ≤15 months old or household contact with known immunodeficiency 1 week after treatment.
  • Allergy to measles vaccine or history of severe reaction to prior measles vaccination.
  • Allergy to iodine.
    • Note: This does not include reactions to intravenous contrast materials.

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Bradley Leibovich, M.D.

Contact us for the latest status

Contact information:

Miriam Green

(904)953-0117

Green.Miriam@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

Bradley Leibovich, M.D.

Contact us for the latest status

Contact information:

Tessa Kroeninger CCRP

(507)538-6107

Kroeninger.Tessa@mayo.edu

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CLS-20389239

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