Active — Not RecruitingPhase 1/2

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

United States34 participantsStarted 2014-04-25

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 * Life expectancy \>= 12 weeks * Willing to provide all biologic specimens as required by the pr…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Count of Participants That Experience a DLT

Timeframe: 28 days

Overall Survival at 12 Months

Timeframe: 12 months

Trial details

NCT IDNCT02068794

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-15

Results submitted2025-05-15

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