Vaccine Therapy and IDO1 Inhibitor INCB024360 in Treating Patients With Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Are in Remission

Summary

This partially randomized phase I/IIb trial studies the side effects vaccine therapy and indoleamine 2,3-dioxygenase (IDO1) inhibitor 4-amino-1,2,5-oxadizaole-3-carboximidamide (INCB024360) and to see how well they work in treating patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in remission. Vaccines made from gene-modified virus may help the body build an effective immune response to kill tumor cells. IDO1 inhibitor INCB024360 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vaccine therapy with IDO1 inhibitor INCB024360 may be an effective treatment for epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Conditions

• Recurrent Fallopian Tube Cancer
• Recurrent Ovarian Epithelial Cancer
• Recurrent Primary Peritoneal Cavity Cancer
• Stage IA Fallopian Tube Cancer
• Stage IA Ovarian Epithelial Cancer
• Stage IA Primary Peritoneal Cavity Cancer
• Stage IB Fallopian Tube Cancer
• Stage IB Ovarian Epithelial Cancer
• Stage IB Primary Peritoneal Cavity Cancer
• Stage IC Fallopian Tube Cancer
• Stage IC Ovarian Epithelial Cancer
• Stage IC Primary Peritoneal Cavity Cancer
• Stage IIA Fallopian Tube Cancer
• Stage IIA Ovarian Epithelial Cancer
• Stage IIA Primary Peritoneal Cavity Cancer
• Stage IIB Fallopian Tube Cancer
• Stage IIB Ovarian Epithelial Cancer
• Stage IIB Primary Peritoneal Cavity Cancer
• Stage IIC Fallopian Tube Cancer
• Stage IIC Ovarian Epithelial Cancer
• Stage IIC Primary Peritoneal Cavity Cancer
• Stage IIIA Fallopian Tube Cancer
• Stage IIIA Ovarian Epithelial Cancer
• Stage IIIA Primary Peritoneal Cavity Cancer
• Stage IIIB Fallopian Tube Cancer
• Stage IIIB Ovarian Epithelial Cancer
• Stage IIIB Primary Peritoneal Cavity Cancer
• Stage IIIC Fallopian Tube Cancer
• Stage IIIC Ovarian Epithelial Cancer
• Stage IIIC Primary Peritoneal Cavity Cancer
• Stage IV Fallopian Tube Cancer
• Stage IV Ovarian Epithelial Cancer
• Stage IV Primary Peritoneal Cavity Cancer

Interventions

BIOLOGICAL

ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine

Given SC

DRUG

IDO1 inhibitor INCB024360

Given PO

OTHER

laboratory biomarker analysis

Correlative studies

OTHER

pharmacological study

Correlative studies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Roswell Park Cancer Institute

  lead OTHER

Principal Investigators

• Kunle Odunsi · Roswell Park Cancer Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-12-31

Primary Completion

2017-09-30