Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
134

Summary

Conditions
  • Fallopian Tube Endometrioid Adenocarcinoma
  • Fallopian Tube Carcinosarcoma
  • Fallopian Tube Clear Cell Adenocarcinoma
  • Primary Peritoneal Endometrioid Adenocarcinoma
  • Recurrent Ovarian Carcinoma
  • Primary Peritoneal Transitional Cell Carcinoma
  • Fallopian Tube Mucinous Adenocarcinoma
  • Ovarian Transitional Cell Carcinoma
  • Primary Peritoneal Undifferentiated Carcinoma
  • Fallopian Tube Serous Adenocarcinoma
  • Fallopian Tube Transitional Cell Carcinoma
  • Ovarian Seromucinous Carcinoma
  • Platinum-Resistant Fallopian Tube Carcinoma
  • Fallopian Tube Undifferentiated Carcinoma
  • Ovarian Carcinosarcoma
  • Ovarian Undifferentiated Carcinoma
  • Ovarian Clear Cell Adenocarcinoma
  • Primary Peritoneal Clear Cell Adenocarcinoma
  • Primary Peritoneal Carcinosarcoma
  • Ovarian Endometrioid Adenocarcinoma
  • Ovarian Serous Adenocarcinoma
  • Platinum-Resistant Ovarian Carcinoma
  • Platinum-Resistant Primary Peritoneal Carcinoma
  • Primary Peritoneal Serous Adenocarcinoma
  • Ovarian Mucinous Adenocarcinoma
  • Recurrent Fallopian Tube Carcinoma
  • Recurrent Primary Peritoneal Carcinoma
Type
Interventional
Phase
Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

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...

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.

Tracking Information

NCT #
NCT02364713
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Evanthia Galanis Mayo Clinic in Rochester