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


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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age ≥ 18 years old.
  • Must have:
    • Recurrent or progressive ovarian cancer, primary peritoneal cancer or fallopian tube 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;
    • Endometroid adenocarcinoma;
    • Mucinous adenocarcinoma;
    • Undifferentiated carcinoma;
    • Clear cell adenocarcinoma;
    • Mixed epithelial carcinoma;
    • Transitional cell carcinoma;
    • Malignant Brenner’s Tumor; or
    • Adenocarcinoma NOS.
  • ECOG performance status (PS) of 0, 1, or 2.
  • The following laboratory values obtained £7 days prior to registration:
    • ANC ≥ 1500/mL;
    • PLT ≥ 100,000/mL;
    • Total bilirubin ≤ upper normal limit;
    • AST ≤ 2 x ULN;
    • Creatinine ≤ 1.5 x ULN;
    • Hgb ≥ 9.0 g/dL.
  • Normal cardiac function as defined by a normal ejection fraction by MUGA or echocardiogram.
  • 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 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.
  • CD4 count count ≥ 200/mL 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 to the abdomen or pelvis.
  • 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 the study team for the most up-to-date information regarding possible participation.

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

(855) 776-0015

More information


Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions