MV-NIS Infected Mesenchymal Stem Cells in Treating Recurrent Ovarian, Primary Peritoneal or Fallopian Tube Cancer

NCT02068794 | Active Not Recruiting Phase 1 Results DMC

• 6 other identifiers: MC1266P50CA136393R01CA200507R01CA136547NCI-2014-0001612-007859
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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 ovarian, primary peritoneal or fallopian tube cancer that has come back. Mesenchymal stem cells may be able to carry tumor-killing substances directly to ovarian, primary peritoneal and fallopian tube cancer cells.

Conditions

Fallopian Tube Clear Cell Adenocarcinoma; Fallopian Tube Endometrioid Adenocarcinoma; Fallopian Tube Mucinous Adenocarcinoma; Fallopian Tube Serous Adenocarcinoma; Fallopian Tube Transitional Cell Carcinoma; Fallopian Tube Undifferentiated Carcinoma; Malignant Ovarian Brenner Tumor; Ovarian Clear Cell Adenocarcinoma; Ovarian Endometrioid Adenocarcinoma; Ovarian Mucinous Adenocarcinoma; Ovarian Seromucinous Carcinoma; Ovarian Serous Adenocarcinoma; Ovarian Transitional Cell Carcinoma; Ovarian Undifferentiated Carcinoma; Primary Peritoneal Serous Adenocarcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma

Outcome Measures

Primary Outcomes (2)

• Count of Participants That Experience a DLT

  Maximum tolerated dose will be defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients).

  28 days

• Overall Survival at 12 Months

  The proportion of patients that were followed and alive at 12 months post registration.

  12 months

Secondary Outcomes (4)

• Tumor Response (Phase II)

  Up to 5 years

• 4 Month Progression Free Survival Rate

  4 months

• Overall Survival (Phase II)

  Up to 5 years

• Progression Free Survival (Phase II)

  Up to 5 years

Other Outcomes (8)

• Time Course of Viral Gene Expression (Phase II)

  Up to 5 years

• Virus Elimination and Biodistribution of Virally Infected Cells by Single Photon Emission Computed Tomography Imaging (Phase II)

  Up to 5 years

• Incidence of Viremia (Phase II)

  Up to 5 years

Study Arms (1)

Treatment (MV-NIS infected mesenchymal stem cells)

EXPERIMENTAL

Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IP over 30 minutes on day 1 of cycle 1 and MV-NIS infected MSC (if MSC are not available, MV-NIS may be given alone) IP over 30 minutes of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo ECHO or MUGA prior to registration and blood sample collection, chest X-ray, SPECT/CT, CT or MRI throughout the study.

Other: Laboratory Biomarker Analysis; Procedure: Mesenchymal Stem Cell Transplantation; Biological: Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter; Procedure: Echocardiography; Procedure: Multigated Acquisition Scan; Procedure: Biospecimen Collection; Procedure: Chest Radiography; Procedure: Single Photon Tomography and Computed Tomography Scan; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (MV-NIS infected mesenchymal stem cells)

Mesenchymal Stem Cell Transplantation PROCEDURE

Given IP

Treatment (MV-NIS infected mesenchymal stem cells)

Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter BIOLOGICAL

Given IP

Also known as: MV-NIS

Treatment (MV-NIS infected mesenchymal stem cells)

Echocardiography PROCEDURE

Undergo ECHO

Also known as: Echocardiograph (EC), echocardiograph, ECHO

Treatment (MV-NIS infected mesenchymal stem cells)

Multigated Acquisition Scan PROCEDURE

Undergo MUGA

Also known as: Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan, MUGA, MUGA Scan, Multi-Gated Acquisition Scan, Radionuclide Ventriculogram Scan, Radionuclide ventriculography, Radionuclide Ventriculography (RNVG), RNVG, SYMA Scanning, Synchronized Multigated Acquisition Scanning

Treatment (MV-NIS infected mesenchymal stem cells)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Blood Sample Collection, Specimen Collection

Treatment (MV-NIS infected mesenchymal stem cells)

Chest Radiography PROCEDURE

Undergo chest X-ray

Also known as: chest x-ray

Treatment (MV-NIS infected mesenchymal stem cells)

Single Photon Tomography and Computed Tomography Scan PROCEDURE

Undergo SPECT/CT

Also known as: SPECT/CT, SPECT/CT SCAN

Treatment (MV-NIS infected mesenchymal stem cells)

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography (CAT), computerized axial tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT SCAN, tomography

Treatment (MV-NIS infected mesenchymal stem cells)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure)Q, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI Scan, MRIs, NMRI, nuclear magnetic resonance imaging, sMRI, Structural MRI

Treatment (MV-NIS infected mesenchymal stem cells)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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, 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 (obtained =\< 7 days prior to registration)
• Platelet (PLT) \>= 100,000/uL (obtained =\< 7 days prior to registration)
• Total bilirubin =\< upper normal limit (obtained =\< 7 days prior to registration)
• Aspartate aminotransferase (AST) =\< 2 x upper limit of normal (ULN) (obtained =\< 7 days prior to registration)
• Creatinine =\< 1.5 x ULN (obtained =\< 7 days prior to registration)
• Hemoglobin (Hgb) \>= 9.0 g/dL (obtained =\< 7 days prior to registration)
• Normal cardiac function as defined by a normal ejection fraction by MUGA (multi gated acquisition scan) or echocardiogram
• Provide informed written consent
• Willing to return to Mayo Clinic Rochester for follow-up

You may not qualify if:

• 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 purified protein derivative (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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Brenner Tumor; Fallopian Tube Neoplasms; Ovarian Neoplasms

Interventions

Mesenchymal Stem Cell Transplantation; Specimen Handling; X-Rays; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms, Fibroepithelial; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Neoplasms by Site; Fallopian Tube Diseases; Endocrine Gland Neoplasms

Intervention Hierarchy (Ancestors)

Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Spectrum Analysis; Chemistry Techniques, Analytical

Results Point of Contact

• Title: Evanthia Galanis MD
• Organization: Mayo Clinic

galanis.evanthia@mayo.edu

(507) 284-2511

Study Officials

• Evanthia Galanis, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2014
• First Posted: February 21, 2014
• Study Start: April 25, 2014
• Primary Completion: March 15, 2024
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 18, 2025
• Results First Posted: July 16, 2025

Record last verified: 2025-11

Locations

US (1)