Gene-Modified T Cells With or Without Decitabine in Treating Patients With Advanced Malignancies Expressing NY-ESO-1

Summary

This phase I/IIa trial studies the side effects and best dose of gene-modified T cells when given with or without decitabine, and to see how well they work in treating patients with malignancies expressing cancer-testis antigens 1 (NY-ESO-1) gene that have spread to other places in the body (advanced). A T cell is a type of immune cell that can recognize and kill abnormal cells of the body. Placing a modified gene for NY-ESO-1 into the patients' T cells in the laboratory and then giving them back to the patient may help the body build an immune response to kill tumor cells that express NY-ESO-1. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving gene-modified T cells with or without decitabine works better in treating patients with malignancies expressing NY-ESO-1.

Conditions

• Advanced Fallopian Tube Carcinoma
• Advanced Malignant Solid Neoplasm
• Advanced Melanoma
• Advanced Ovarian Carcinoma
• Advanced Primary Peritoneal Carcinoma
• Advanced Synovial Sarcoma
• Clinical Stage III Cutaneous Melanoma AJCC v8
• Clinical Stage IV Cutaneous Melanoma AJCC v8
• Metastatic Fallopian Tube Carcinoma
• Metastatic Melanoma
• Metastatic Ovarian Carcinoma
• Metastatic Primary Peritoneal Carcinoma
• Metastatic Synovial Sarcoma
• Pathologic Stage III Cutaneous Melanoma AJCC v8
• Pathologic Stage IIIA Cutaneous Melanoma AJCC v8
• Pathologic Stage IIIB Cutaneous Melanoma AJCC v8
• Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
• Pathologic Stage IIID Cutaneous Melanoma AJCC v8
• Pathologic Stage IV Cutaneous Melanoma AJCC v8
• Platinum-Resistant Fallopian Tube Carcinoma
• Platinum-Resistant Ovarian Carcinoma
• Platinum-Resistant Primary Peritoneal Carcinoma
• Stage III Fallopian Tube Cancer AJCC v8
• Stage III Ovarian Cancer AJCC v8
• Stage III Primary Peritoneal Cancer AJCC v8
• Stage IIIA Fallopian Tube Cancer AJCC v8
• Stage IIIA Ovarian Cancer AJCC v8
• Stage IIIA Primary Peritoneal Cancer AJCC v8
• Stage IIIA1 Fallopian Tube Cancer AJCC v8
• Stage IIIA1 Ovarian Cancer AJCC v8
• Stage IIIA2 Fallopian Tube Cancer AJCC v8
• Stage IIIA2 Ovarian Cancer AJCC v8
• Stage IIIB Fallopian Tube Cancer AJCC v8
• Stage IIIB Ovarian Cancer AJCC v8
• Stage IIIB Primary Peritoneal Cancer AJCC v8
• Stage IIIC Fallopian Tube Cancer AJCC v8
• Stage IIIC Ovarian Cancer AJCC v8
• Stage IIIC Primary Peritoneal Cancer AJCC v8
• Stage IV Fallopian Tube Cancer AJCC v8
• Stage IV Ovarian Cancer AJCC v8
• Stage IV Primary Peritoneal Cancer AJCC v8
• Stage IVA Fallopian Tube Cancer AJCC v8
• Stage IVA Ovarian Cancer AJCC v8
• Stage IVA Primary Peritoneal Cancer AJCC v8
• Stage IVB Fallopian Tube Cancer AJCC v8
• Stage IVB Ovarian Cancer AJCC v8
• Stage IVB Primary Peritoneal Cancer AJCC v8
• Unresectable Melanoma
• Unresectable Ovarian Carcinoma
• Unresectable Synovial Sarcoma

Interventions

DRUG

Cyclophosphamide

Given IV

DRUG

Decitabine

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

PROCEDURE

Leukapheresis

Undergo leukapheresis

BIOLOGICAL

TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Roswell Park Cancer Institute

  lead OTHER

Principal Investigators

• Philip McCarthy, MD · Roswell Park Cancer Institute

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-07-14

Primary Completion

2021-03-04

Completion

2032-07-14

FDA Drug

Yes

Countries

• United States

Study Locations