CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 7 enrolled
Drug / intervention
ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01536054
NCT01536054Phase 1Completed
CompareCT.gov

A Phase I Clinical Trial of mTOR Inhibition With Sirolimus for Enhancing ALVAC(2)-NY-ESO-1(M)/TRICOM Vaccine Induced Anti-Tumor Immunity in Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

Roswell Park Cancer Institute·interventional·Posted Feb 20, 2012·Updated Mar 27, 2020

In Brief

A Phase 1 clinical trial evaluating ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine, sirolimus, and 2 other interventions for Recurrent Fallopian Tube Cancer and 23 related conditions. Completed, enrolled 7 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent 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
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), Sanofi Pasteur, a Sanofi Company

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 20, 2012
Enrollment StartAug 20, 2012
Primary CompletionApr 21, 2015
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 14.4 years ago

Interventions

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

Given SC

sirolimusdrug

Given PO

laboratory biomarker analysisother

Correlative studies

sargramostimbiological

Given SC