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.
PRIMARY OBJECTIVE: I. Compare clinical efficacy of Arm A (MV-NIS therapy) and Arm B (standard cytotoxic chemotherapy), as measured by overall survival (OS). SECONDARY OBJECTIVES: I. Compare progression-free survival (PFS), overall survival at 12 months (OS12), progression-free survival at six months (PFS6), and objective response rate (ORR) between MV-NIS therapy and standard chemotherapy. II. Assess safety and tolerability of MV-NIS, and compare with standard chemotherapy. III. Compare quality of life as assessed by Functional Assessment of Cancer Therapy-Ovarian (FACT-O) between MV-NIS and standard chemotherapy. TRANSLATIONAL OBJECTIVES: I. 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 using single-photon emission computerized tomography (SPECT)/computed tomography (CT) imaging within the MV-NIS treatment arm. II. Assess viremia, viral replication, and viral shedding/persistence following intraperitoneal administration within the NV-NIS treatment arm. III. Measure humoral and cellular immune responses to MV-NIS within the NV-NIS treatment arm. IV. Measure changes in anti-ovarian cancer (OC) immune responses in both treatment arms. V. Perform transcriptomic analysis on tumor biopsy specimens to determine a gene expression profile predictive of therapeutic response to MV-NIS. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter intraperitoneally (IP) over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive pegylated liposomal doxorubicin hydrochloride intravenously (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. After completion of study treatment, patients are followed up every 3 months until disease progression and then every 6 months for 5 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Given IV
Given IV
Correlative studies
Given IP
Given IV
Given IV
Ancillary studies
Given IV
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
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.
Time frame: 5 years
Progression-free Survival
Defined as the time from start of study therapy to the date of first observation of disease progression or death due to any cause (whichever comes first). The distribution of progression-free survival for both arms of the study will be estimated using the Kaplan-Meier method.
Time frame: 11 months
Overall Survival
Defined as the time from registration/randomization to death due to all causes. Overall survival at 12 months distributions both arms of the study will be estimated using the Kaplan-Meier method and be compared using a one-sided logrank test.
Time frame: 12 months
Progression-free Survival
Progression-free survival at 6 months distributions both arms of the study will be estimated using the Kaplan-Meier method.
Time frame: 6 months
Objective Response Rate
Objective response rate is defined to be a complete response or partial response noted as the objective status on 2 consecutive evaluations at least 4 weeks apart
Time frame: 11 months
Incidence of Adverse Events Per Common Terminology Criteria for Adverse Events Version 4.0
Safety and tolerability of the oncolytic measles virus encoding thyroidal sodium iodide symporter as compared to standard therapy will be evaluated using all patients who have received any study treatment as well as summarizing those who have been included in the efficacy analyses. The overall adverse event rates for grade 3 or higher adverse events will be compared between arms.
Time frame: 12 months
Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Ovarian Questionnaire
Quality of life as measured by the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) questionnaire will be compared between treatment arms. The assessment will be scored according to the assessment scoring algorithm at each collection time. Scores at end of each cycle will be compared using Wilcoxon procedures. The FACT-O consist of 39 questions, each answered on a 5-point Likert scale ranging from 0 (Not at all) to 4 (Very much). Possible total scores range from 0-156, with higher scores indicating better quality of life. We will calculate the mean change from the start to the end of the study of patient total FACT-O point sum by arm.
Time frame: 5 years
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