Gene-Modified T Cells, Vaccine Therapy, and Ipilimumab in Treating Patients With Locally Advanced or Metastatic Malignancies

Summary

This pilot phase I trial studies the side effects of taking ipilimumab after gene-modified T cells and vaccine therapy when treating patients with advanced cancer that has spread to other areas of the body and has not responded to standard therapies. This trial also will determine the best dose of Ipilimumab to use in this combination treatment. T cells are a special type of white blood cell (immune cell) that have the ability to kill cancer cells. T cells are taken from the blood and modified in the laboratory to recognize a specific protein expressed on cancer cells, called NY-ESO-1. This may allow the T cells to target and kill cancer cells that express that protein. Dendritic cells are another type of blood cell that can teach other cells in the body to look for cancer cells and attack them. Giving a dendritic cell vaccine with the NY-ESO-1 protein may help dendritic cells teach the immune system to target cancer cells expressing that protein, and further help the T cells attack cancer. Ipilimumab is a monoclonal antibody, a type of drug manufactured in the laboratory that is similar to antibodies made in the human body that fight off infection. Ipilimumab blocks a protein that turns down the immune system, so blocking this protein may make the immune system more active. This may increase the ability of immune cells to kill cancer cells and improve the effectiveness of the T cell transplant. Giving gene-modified T-cells, a dendritic cell vaccine, and ipilimumab together may teach the immune system to recognize and kill cancer cells that have the NY-ESO-1 protein.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

DRUG

cyclophosphamide

Given IV

DRUG

fludarabine phosphate

Given IV

BIOLOGICAL

NY-ESO-1 reactive TCR retroviral vector transduced autologous PBL

Given NY-ESO-1 reactive TCR retroviral vector transduced autologous T cells IV

BIOLOGICAL

dendritic cell vaccine therapy

NY-ESO-1157-165 peptide pulsed DC vaccine given ID

BIOLOGICAL

aldesleukin

Given SC

RADIATION

fludeoxyglucose F 18

Correlative studies

PROCEDURE

positron emission tomography

Correlative studies

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Jonsson Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Antoni Ribas · Jonsson Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-07-17

Primary Completion

2018-12-18

Completion

2018-12-18

Countries

• United States

Study Locations