MV-NIS or Investigator's Choice Chemotherapy in Treating Patients With Ovarian, Fallopian, or Peritoneal Cancer

NCT02364713 | Terminated Phase 2 Results DMC

• 3 other identifiers: MC1365NCI-2015-0013314-000428
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 3

Brief Summary

This randomized phase II trial studies how well oncolytic measles virus encoding thyroidal sodium iodide symporter (MV-NIS) compared to investigator's choice chemotherapy works in treating patients with ovarian, fallopian, or peritoneal cancer. Measles virus, which has been changed in a certain way, may be able to kill tumor cells without damaging normal 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; Ovarian Carcinosarcoma; Ovarian Clear Cell Adenocarcinoma; Ovarian Endometrioid Adenocarcinoma; Ovarian Mucinous Adenocarcinoma; Ovarian Seromucinous Carcinoma; Ovarian Serous Adenocarcinoma; Ovarian Transitional Cell Carcinoma; Ovarian Undifferentiated Carcinoma; Platinum-Resistant Ovarian Carcinoma; Platinum-Resistant Primary Peritoneal Carcinoma; Primary Peritoneal Carcinosarcoma; Primary Peritoneal Clear Cell Adenocarcinoma; Primary Peritoneal Endometrioid Adenocarcinoma; Primary Peritoneal Serous Adenocarcinoma; Primary Peritoneal Transitional Cell Carcinoma; Primary Peritoneal Undifferentiated Carcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma; Fallopian Tube Carcinosarcoma; Platinum-Resistant Fallopian Tube Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Defined as the time from registration/randomization to death due to all causes. Will be a comparison of the oncolytic measles virus encoding thyroidal sodium iodide symporter versus investigator's choice chemotherapy using a one-sided log-rank test.

  5 years

Secondary Outcomes (6)

• Progression-free Survival

  11 months

• Overall Survival

  12 months

• Progression-free Survival

  6 months

• Objective Response Rate

  11 months

• Incidence of Adverse Events Per Common Terminology Criteria for Adverse Events Version 4.0

  12 months

Other Outcomes (5)

• Time Course of Viral Gene Expression and Virus Elimination and Biodistribution of Virally Infected Cells Using Single-photon Emission Computerized Tomography/Computed Tomography Imaging

  Up to course 2

• Viremia, Viral Replication, and Viral Shedding/Persistence Following Intraperitoneal Administration Within the Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter Treatment Arm

  Up to 5 years

• Humoral and Cellular Immune Responses to Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter

  Up to 5 years

Study Arms (2)

Arm A (MV-NIS)

EXPERIMENTAL

Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IP over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Other: Laboratory Biomarker Analysis; Biological: Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter; Other: Quality-of-Life Assessment

Arm B (DOXIL, GEM, TOPA, TAXOL)

ACTIVE COMPARATOR

Patients receive pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 1, or gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15, or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15, or paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may also receive bevacizumab IV over 30-90 minutes on days 1 and 15 with pegylated liposomal doxorubicin hydrochloride, topotecan hydrochloride, or paclitaxel. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Biological: Bevacizumab; Drug: Gemcitabine Hydrochloride; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel; Drug: Pegylated Liposomal Doxorubicin Hydrochloride; Other: Quality-of-Life Assessment; Drug: Topotecan Hydrochloride

Interventions

Pegylated Liposomal Doxorubicin Hydrochloride DRUG

Given IV

Also known as: ATI-0918, Caelyx, Dox-SL, Doxil, Doxilen, Doxorubicin HCl Liposomal, Doxorubicin HCl Liposome, Doxorubicin Hydrochloride Liposome, Duomeisu, Evacet, LipoDox, Lipodox 50, Liposomal Adriamycin, Liposomal Doxorubicin Hydrochloride, Liposomal-Encapsulated Doxorubicin, Pegylated Doxorubicin HCl Liposome, S-Liposomal Doxorubicin, Stealth Liposomal Doxorubicin, TLC D-99

Arm B (DOXIL, GEM, TOPA, TAXOL)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm A (MV-NIS); Arm B (DOXIL, GEM, TOPA, TAXOL)

Topotecan Hydrochloride DRUG

Given IV

Also known as: Hycamptamine, Hycamtin, SKF S-104864-A, Topotecan HCl, topotecan hydrochloride (oral)

Arm B (DOXIL, GEM, TOPA, TAXOL)

Bevacizumab BIOLOGICAL

Given IV

Also known as: Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb, Avastin, Bevacizumab awwb, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Bevacizumab Biosimilar CBT 124, Bevacizumab Biosimilar CT-P16, Bevacizumab Biosimilar FKB238, Bevacizumab Biosimilar HD204, Bevacizumab Biosimilar HLX04, Bevacizumab Biosimilar IBI305, Bevacizumab Biosimilar LY01008, Bevacizumab Biosimilar MIL60, Bevacizumab Biosimilar QL 1101, Bevacizumab Biosimilar RPH-001, Bevacizumab Biosimilar SCT501, BP102, BP102 Biosimilar, HD204, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF, SCT501

Arm B (DOXIL, GEM, TOPA, TAXOL)

Gemcitabine Hydrochloride DRUG

Given IV

Also known as: dFdCyd, Difluorodeoxycytidine Hydrochloride, FF 10832, FF-10832, FF10832, Gemcitabine HCI, Gemzar, LY-188011, LY188011

Arm B (DOXIL, GEM, TOPA, TAXOL)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm A (MV-NIS); Arm B (DOXIL, GEM, TOPA, TAXOL)

Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter BIOLOGICAL

Given IP

Also known as: MV-NIS

Arm A (MV-NIS)

Paclitaxel DRUG

Given IV

Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

Arm B (DOXIL, GEM, TOPA, TAXOL)

Eligibility Criteria

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

You may qualify if:

• Ability to understand and the willingness to sign a written informed consent document
• The effects of the candidate chemoprevention agents on the developing human fetus remain incompletely defined; however, study participants will be women who have gone through a bi-lateral oophorectomy procedure
• Willingness to be evaluated for surgical placement of an intraperitoneal port and undergo biopsy if feasible for a research sample
• Recurrent, persistent, or progressive epithelial ovarian, fallopian tube, or primary peritoneal cancer after treatment with bilateral oophorectomy and either cisplatin or carboplatin and either paclitaxel, albumin-bound paclitaxel, or docetaxel; histologic confirmation of the primary tumor is required; eligible histologies include serous, endometrioid, clear cell, mucinous, transitional cell, undifferentiated, or mixed carcinoma
• Platinum-resistant or platinum-refractory disease, defined as either 1) less than a complete response to the most recent carboplatin- or cisplatin-containing chemotherapy regimen, 2) serum cancer antigen (CA)-125 \>= 2 x upper limit of normal (ULN) within 180 days of last dose of carboplatin- or cisplatin-containing chemotherapy, confirmed by a second CA-125 (the second CA-125 does not have to be within 180 days of chemotherapy), or 3) CT or positron emission tomography (PET)/CT evidence of cancer recurrence within 180 days of last dose of carboplatin- or cisplatin-containing chemotherapy
• 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 =\< ULN (obtained =\< 7 days prior to registration)
• Aspartate aminotransferase (AST) =\< 2 x 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)
• Willingness to return to Mayo Clinic Rochester or another participating institution for follow-up; patients who are randomized to Arm B (cytotoxic chemotherapy) may receive chemotherapy at any oncology clinic able to provide the protocol-directed therapy and willing to send laboratory data to the participating institution; however, patients must be willing to return to the participating institution every two months for evaluation; patients who are randomized to Arm A must be willing to receive all treatment and follow-up at a participating institution
• Life expectancy \>= 12 weeks
• Willingness to provide all biologic specimens as required by the protocol
• Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, or evaluable disease by CA-125; (NOTE: CA-125-evaluable disease is defined as serum CA-125 \>= 2 x ULN that is determined by the treating clinician to be due to recurrent ovarian, fallopian tube, or primary peritoneal cancer)

You may not qualify if:

• Epithelial tumors of low malignant potential, stromal tumors, and germ cell tumors of the ovary
• Evidence of measurable disease (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST 1.1\]) outside of the peritoneal cavity (ex: mediastinal lymphadenopathy, parenchymal liver metastasis, or symptomatic pleural effusion proven or suspected to be due to cancer)
• Note: Asymptomatic pleural effusion with or without minimal pleural involvement as long as there is no measurable disease outside the peritoneum/retroperitoneum is allowed
• Bulky metastases, defined as any tumor nodule or lymph nodes \> 5 cm in greatest dimension on axial images on pre-treatment CT, PET/CT, or magnetic resonance imaging (MRI)
• Note: patients with bulky (\> 5 cm) disease for whom gross total cytoreduction is deemed feasible by a surgeon (with confirmation by a second surgeon after radiologic review) are eligible for participation in the context of cytoreductive surgery
• Resistant to all of the following: DOXIL, gemcitabine hydrochloride (GEM), topotecan hydrochloride (TOPA), and weekly paclitaxel (TAXOL); (NOTE: resistance is defined as either 1) less than a complete response to any chemotherapy regimen containing the agent in question \[consider weekly TAXOL as a separate agent from every-three-week TAXOL\], 2) serum CA-125 \>= 2 x ULN within 180 days of last dose of chemotherapy containing the agent in question, confirmed by a second CA-125 \[the second CA-125 does not have to be within 180 days of chemotherapy\], or 3) CT or PET/CT evidence of cancer recurrence/progression within 180 days of last dose of chemotherapy containing the agent in question; \[for example, if a patient previously received carboplatin and GEM, had a complete response, and had initial evidence of relapse \> 180 days after the last dose of GEM, that patient would not be considered resistant to GEM\])
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 3 or 4
• 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)
• Active infection =\< 7 days prior to study entry
• Any of the following prior therapies:
• Chemotherapy =\< 3 weeks prior to study entry
• Immunotherapy =\< 4 weeks prior to study entry
• Biologic therapy =\< 4 weeks prior to study entry
• Extensive abdominal surgery if it includes enterotomy(ies) =\< 3 weeks prior to study entry; (NOTE: this criterion does not apply to placement of the peritoneal Port-A-Cath or lysis of adhesions at the time of study entry)
• Any viral or gene therapy prior to study entry

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms

Interventions

Bevacizumab; Immunoglobulin G; Disulfides; Gemcitabine; Paclitaxel; Taxes; liposomal doxorubicin; Doxorubicin; Topotecan

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Immunoglobulin Isotypes; Sulfides; Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrogen Sulfide; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Camptothecin; Alkaloids

Results Point of Contact

• Title: Evanthia Galanis
• Organization: Mayo Clinic

galanis.evanthia@mayo.edu

507-266-0584

Study Officials

• Evanthia Galanis, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: February 18, 2015
• Study Start: March 13, 2015
• Primary Completion: January 13, 2022
• Study Completion: January 13, 2022
• Last Updated: December 11, 2025
• Results First Posted: November 17, 2025

Record last verified: 2025-08

Locations

US (3)