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Fallopian Tube Clear Cell AdenocarcinomaPhase 1/2NCT02068794

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

A Phase 1/2 study testing Laboratory Biomarker Analysis, Mesenchymal Stem Cell Transplantation and Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter in people with Fallopian Tube Clear Cell Adenocarcinoma and Fallopian Tube Endometrioid Adenocarcinoma, run by Mayo Clinic at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Laboratory Biomarker Analysis, Mesenchymal Stem Cell Transplantation and Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteUnited States
Study dates
25 Apr 2014to 15 Mar 2027
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • 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
  • CD4 count >= 200/uL or >= 15% of peripheral blood lymphocytes

Who cannot join

  • 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:
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Phase I/II Trial of Intraperitoneal Administration of Adipose Tissue Derived Mesenchymal Stem Cells Infected With a NIS-Expressing Derivative Manufactured From a Genetically Engineered Strain of Measles Virus in Patients With Recurrent Ovarian Cancer

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the maximally tolerated dose (MTD) of intraperitoneal administration of an Edmonston's strain measles virus genetically engineered to produce sodium iodine symporter (NIS) (measles virus [MV]-NIS) in patients with recurrent ovarian cancer, delivered by adipose tissue derived mesenchymal stem cells (MSC). (Phase I) II. To assess the 12 month overall survival of patients treated with this regimen. (Phase II)

SECONDARY OBJECTIVES:

  1. To assess the tolerability of this regimen. (Phase II) II. To assess the 4 month progression free survival of patients treated with this regimen. (Phase II) III. To assess the response rate, progression-free survival, and overall survival of patients treated with this regimen. (Phase II)

TRANSLATIONAL OBJECTIVES:

  1. To assess the time course of viral gene expression and virus elimination and biodistribution of virally infected cells at various time points after infection with MV-NIS versus MSC delivered MV-NIS using single-photon emission computed tomography (SPECT)/computed tomography (CT) imaging. (Phase II) II. To assess viremia, viral replication, and measles virus shedding/persistence following intraperitoneal administration. (Phase II) III. To assess humoral and cellular immune response to the injected virus. (Phase II) IV. To assess in a preliminary fashion the development of antitumor immune response. (Phase II)

OUTLINE: This is a phase I, dose-escalation study followed by phase II study.

Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter intraperitoneally (IP) over 30 minutes on day 1 of cycle 1 and MV-NIS infected mesenchymal stem cells (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 echocardiography (ECHO) or multigated acquisition scan (MUGA) prior to registration and blood sample collection, chest X-ray, SPECT/CT, CT or magnetic resonance imaging (MRI) throughout the study.

After completion of study treatment, patients are followed up every 6 months for up to 5 years.

Being tested
Laboratory Biomarker Analysis, Mesenchymal Stem Cell Transplantation, Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter, Echocardiography, Multigated Acquisition Scan
Medical subject headings
Brenner Tumor, Fallopian Tube Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Mesenchymal Stem Cell TransplantationProcedure or surgery

    Given IP

  • Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide SymporterBiological

    Also called MV-NIS

    Given IP

  • EchocardiographyProcedure or surgery

    Also called Echocardiograph (EC), echocardiograph, ECHO

    Undergo ECHO

  • Multigated Acquisition ScanProcedure or surgery

    Also called Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan

    Undergo MUGA

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Blood Sample Collection, Specimen Collection

    Undergo blood sample collection

  • Chest RadiographyProcedure or surgery

    Also called chest x-ray

    Undergo chest X-ray

  • Single Photon Tomography and Computed Tomography ScanProcedure or surgery

    Also called SPECT/CT, SPECT/CT SCAN

    Undergo SPECT/CT

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography (CAT), computerized axial tomography

    Undergo CT

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure)Q, Magnetic Resonance Imaging Scan

    Undergo MRI

Study groups in NCT02068794
Study groupRoleWhat they receive
Treatment (MV-NIS infected mesenchymal stem cells)ExperimentalPatients 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 28 days

  2. Overall Survival at 12 Months

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

    Measured: 12 months

Secondary outcomes (4)

  1. Tumor Response

    A confirmed tumor response is defined to be a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response. CR(complete response) is determined by the disappearance of all target lesions and normalization of CA125 if elevated at baseline. PR(partial response) is determined by at least 30% decrease in the sum of the longest diameter (LD) of target lesion taking as reference the baseline sum LD.

    Measured: 5 years

  2. 4 Month Progression Free Survival Rate

    Defined as the proportion of patients alive and progression free at 4 months.

    Measured: 4 months

  3. Overall Survival (Phase II)

    Defined as the length of time from study registration to date of death due to any cause. The distribution of survival time will be estimated using Kaplan-Meier survival curves and logrank tests.

    Measured: Up to 5 years

  4. Progression Free Survival (Phase II)

    Progression-free survival (PFS) is defined as the length of time from study registration to the first of either death due to any cause or progression. The distribution of PFS will be estimated using Kaplan-Meier survival curves and logrank tests. In addition, comparisons of overall PFS in patients treated with MV-NIS/MSC will be made to patients enrolled on the prior MV-CEA and MV-NIS trial in an exploratory manner.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2014 (estimated)
  2. Study start25 Apr 2014
  3. Primary completion15 Mar 2024
  4. Study completion15 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02068794
Sponsor's protocol ID
MC1266
Other IDs
P50CA136393, R01CA200507, R01CA136547, 12-007859
Status last verified
Aug 2026
First submitted
19 Feb 2014
Last updated
24 Aug 2026
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Laboratory Biomarker Analysis, Mesenchymal Stem Cell Transplantation and Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter in people with Fallopian Tube Clear Cell Adenocarcinoma and Fallopian Tube Endometrioid Adenocarcinoma, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Count of Participants That Experience a DLT (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02068794.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.

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