MV-NIS Infected Mesenchymal Stem Cells in Treating Patients With Recurrent Ovarian Cancer


  • Study type

  • Study phase

  • 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
    • Rochester, Minnesota: 12-007859
    NCT ID: NCT02068794
    Sponsor Protocol Number: MC1266

About this study

This phase I/II trial studies the side effects and best dose of oncolytic measles virus encoding thyroidal sodium iodide symporter (MV-NIS) infected mesenchymal stem cells and to see how well it works in treating patients with recurrent ovarian cancer. Mesenchymal stem cells may be able to carry tumor-killing substances directly to ovarian cancer cells.

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:

  • Must have:
    • Recurrent or progressive ovarian cancer or primary peritoneal cancer after prior treatment with platinum and taxanes
    • Histologic confirmation of the original primary tumor
    • Prior bilateral oophorectomy
  • The following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (NOS)
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2
  • Absolute neutrophil count (ANC) ≥ 1500/uL
  • Platelet (PLT) ≥ 100,000/uL
  • Total bilirubin ≤ upper normal limit
  • Aspartate aminotransferase (AST) ≤ 2 x upper limit of normal (ULN)
  • Creatinine ≤ 1.5 x ULN
  • Hemoglobin (Hgb) ≥ 9.0 g/dL
  • Normal cardiac function as defined by a normal ejection fraction by multi gated acquisition scan (MUGA) or echocardiogram
  • Normal oxygen saturation at baseline ABG (arterial blood gas) testing
  • The following pulmonary function tests (PFT) values in baseline:
    • Forced expiratory volume (FEV)1 > 2 liters (Lt)
    • FEV1/forced vital capacity (FVC) > 50%
    • Residual volume (RV)/total lung capacity (TLV) < 50%
  • Provide informed written consent
  • Willing to return to Mayo Clinic Rochester for follow-up
  • Life expectancy ≥ 12 weeks
  • Willing to provide all biologic specimens as required by the protocol
  • Measurable disease by exam or CT scan, or for patients with cancer antigen (CA)-125 elevation or with microscopic residual but without measurable disease on imaging, willingness to undergo laparoscopy for evaluation of treatment effect if no radiographic progression after 6 treatment cycles
  • Cluster of differentiation (CD)4 count ≥ 200/uL or ≥ 15% of peripheral blood lymphocytes

Exclusion Criteria:

  • Epithelial tumors of low malignant potential, stromal tumors, and germ cell tumors of the ovary
  • Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy; subjects will be excluded if this is their first relapse and they have recurred > 6 months from completion of primary (adjuvant) chemotherapy
  • Active infection ≤ 5 days prior to registration
  • History of tuberculosis or history of tuberculosis skin test (PPD) positivity
  • History of other malignancy ≤ 5 years prior to registration except for non-melanoma skin cancer, carcinoma in situ of the cervix, and ductal carcinoma in situ (DCIS)
  • Any of the following prior therapies:
    • Chemotherapy ≤ 3 weeks prior to registration
    • Immunotherapy ≤ 4 weeks prior to registration
    • Biologic therapy ≤ 4 weeks prior to registration
    • Extensive abdominal surgery if it includes enterotomy(ies) ≤ 3 weeks prior to registration; this criterion does not apply to placement of the peritoneal Port-A-Cath or lysis of adhesions at the time of registration
    • Any viral or gene therapy prior to registration
    • Radiation therapy
  • New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or known cardiac arrhythmias (atrial fibrillation or supraventricular tachycardia [SVT])
  • Other cardiac or pulmonary disease that, at the investigators discretion, can impair treatment safety
  • Requiring blood product support
  • Central nervous system (CNS) metastases or seizure disorder
  • Human immunodeficiency virus (HIV)-positive test result or history of other immunodeficiency
  • History of organ transplantation
  • History of chronic hepatitis B or C
  • Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration [FDA]-approved indication and in the context of a research investigation)
  • Intra-abdominal disease > 8 cm in diameter at the time of registration, intrahepatic disease, or disease beyond the abdominal cavity; patients with intra-abdominal lymph node involvement are eligible based on biodistribution data indicating viral dissemination to lymph nodes following intraperitoneal administration
  • Treatment with oral/systemic corticosteroids, with the exception of topical or inhaled steroids
  • Exposure to household contacts ≤ 15 months old or household contact with known immunodeficiency
  • Allergy to measles vaccine or history of severe reaction to prior measles vaccination
  • Allergy to iodine; this does not include reactions to intravenous contrast materials
  • Any other pathology or condition where the principle investigator may deem to negatively impact treatment safety

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Evanthia Galanis, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office



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