MV-NIS Infected Mesenchymal Stem Cells in Treating Recurrent Ovarian, Primary Peritoneal or Fallo… (NCT02068794) | Clinical Trial Compass
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 range18 Years
SexALL
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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…