Ovarian Cancer Clinical Trial
MV-NIS Infected Mesenchymal Stem Cells in Treating Patients With Recurrent Ovarian, Primary Peritoneal or Fallopian Tube 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.
I. 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)
I. 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)
I. 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.
After completion of study treatment, patients are followed up every 6 months for up to 5 years.
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 multi gated acquisition scan (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 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
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
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
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