Sirolimus and Vaccine Therapy in Treating Patients With Stage II-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer

Summary

This phase I trial studies the side effects and best dose and schedule of sirolimus when given together with vaccine therapy in treating patients with stage II-IV ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer. Sirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy together with sirolimus may be an effective treatment for ovarian, fallopian tube, or primary peritoneal cancer

Conditions

• Recurrent Fallopian Tube Cancer
• Recurrent Ovarian Epithelial Cancer
• Recurrent 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

sirolimus

Given PO

OTHER

laboratory biomarker analysis

Correlative studies

BIOLOGICAL

sargramostim

Given SC

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Sanofi Pasteur, a Sanofi Company

  collaborator INDUSTRY

• Roswell Park Cancer Institute

  lead OTHER

Principal Investigators

• Kunle Odunsi · Roswell Park Cancer Institute

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-08-20

Primary Completion

2015-04-21

Completion

2015-04-21

Countries

• United States

Study Locations