Clinical Trials Directory

Trials / Completed

CompletedNCT01522820

Vaccine Therapy With or Without Sirolimus in Treating Patients With NY-ESO-1 Expressing Solid Tumors

A Phase I Clinical Trial of mTOR Inhibition With Rapamycin for Enhancing Intranodal Dendritic Cell Vaccine Induced Anti-tumor Immunity in Patients With NY-ESO-1 Expressing Solid Tumors

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
18 (actual)
Sponsor
Roswell Park Cancer Institute · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase I trial studies the side effects and best schedule of vaccine therapy with or without sirolimus in treating patients with cancer-testis antigen (NY-ESO-1) expressing solid tumors. Biological therapies, such as sirolimus, may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells that express NY-ESO-1. Infusing the vaccine directly into a lymph node may cause a stronger immune response and kill more tumor cells. It is not yet known whether vaccine therapy works better when given with or without sirolimus in treating solid tumors.

Detailed description

PRIMARY OBJECTIVES: I. Determine the safety of DC205-NY-ESO-1 vaccine (DEC-205/NY-ESO-1 fusion protein CDX-1401) with and without sirolimus. Toxicity as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. SECONDARY OBJECTIVES: I. Assess the NY-ESO-1 specific cellular and humoral immunity: * Peripheral blood NY-ESO-1 specific cluster of differentiation (CD)8+ and CD4+ T-cells. * Peripheral blood NY-ESO-1 specific antibodies. * Peripheral blood frequency of CD4+CD25+forkhead box P3 (FOXP3)+ regulatory T-cells. TERTIARY OBJECTIVES: I. Explore time to disease progression. OUTLINE: Patients undergo standard collection of peripheral white blood cells via leukapheresis over 90-240 minutes for vaccine preparation. Patients are assigned sequentially to Cohorts 1a-1d. COHORT 1a: Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 intranodally on days 1, 29, 57, and 113. COHORT 1b: Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 as in Cohort 1a and sirolimus orally (PO) on days 1-14, 29-42, and 57-70. COHORT 1c: Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 as in Cohort 1a and sirolimus PO or percutaneous endoscopic gastrostomy (PEG) tube on days 15-28, 43-56, and 71-84. COHORT 1d: Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 as in Cohort 1a and sirolimus PO or PEG on days 1-84. COHORT 2: Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 as in the Cohort (1a-1d) that is determined to be safe and produces optimal immunological effects and sirolimus PO on days 1-14 as in Cohort 1b dose. After completion of study treatment, patients are followed up at 6 weeks, 6 months and 12 months.

Conditions

Interventions

TypeNameDescription
BIOLOGICALDEC-205/NY-ESO-1 Fusion Protein CDX-1401Given intranodally
OTHERLaboratory Biomarker AnalysisCorrelative studies
OTHERPharmacological StudyCorrelative studies
DRUGSirolimusGiven PO or PEG

Timeline

Start date
2012-03-01
Primary completion
2016-07-01
Completion
2016-07-01
First posted
2012-02-01
Last updated
2016-10-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01522820. Inclusion in this directory is not an endorsement.