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TAC Chemotherapy and Pembrolizumab Plus Interleukin-12 Gene Therapy and L-NMMA in Triple Negative Breast Cancer

2019-09-25 06:13:39 | BioPortfolio

Summary

The purpose of this research study is to test the safety and effectiveness of adding interleukin 12 (IL-12) gene therapy and L-NMMA to pembrolizumab in patients with early-stage triple negative breast cancer (TNBC) receiving standard of care preoperative (neoadjuvant) chemotherapy.

Description

The purpose of this research study is to test the safety and effectiveness of adding interleukin 12 (IL-12) gene therapy and L-NMMA to pembrolizumab in patients with early-stage triple negative breast cancer (TNBC) receiving standard of care neoadjuvant chemotherapy. Chemotherapy given before breast cancer surgery is called neoadjuvant chemotherapy. It shrinks the breast tumor so it is easier to remove during surgery. Docetaxel, doxorubicin, and cyclophosphamide chemotherapy (called TAC chemotherapy) is often used for the neoadjuvant treatment of breast cancer. Unfortunately, a lot of breast tumors do not shrink with TAC chemotherapy treatment.

Pembrolizumab is a type of treatment that stimulates your own immune system to attack cancer cells. Your immune system is normally your body's first defense against threats like cancer. However, sometimes cancer cells produce signals that prevent the immune system from detecting and killing them. Pembrolizumab helps your immune system so it can detect and attack cancer cells. Chemotherapy plus pembrolizumab has been shown to be better than chemotherapy alone for shrinking breast tumors before surgery. To increase the cancer-fighting ability of your immune system, you will be given 1 or 2 more treatments. These include IL-12 gene therapy and L-NMMA.

Study Design

Conditions

Triple Negative Breast Cancer

Intervention

Docetaxel, Doxorubicin, Cyclophosphamide, Pembrolizumab, IL-12 gene therapy, L-NMMA

Location

Houston Methodist Cancer Center
Houston
Texas
United States
77030

Status

Not yet recruiting

Source

The Methodist Hospital System

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-25T06:13:39-0400

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Medical and Biotech [MESH] Definitions

The introduction of new genes into cells for the purpose of treating disease by restoring or adding gene expression. Techniques include insertion of retroviral vectors, transfection, homologous recombination, and injection of new genes into the nuclei of single cell embryos. The entire gene therapy process may consist of multiple steps. The new genes may be introduced into proliferating cells in vivo (e.g., bone marrow) or in vitro (e.g., fibroblast cultures) and the modified cells transferred to the site where the gene expression is required. Gene therapy may be particularly useful for treating enzyme deficiency diseases, hemoglobinopathies, and leukemias and may also prove useful in restoring drug sensitivity, particularly for leukemia.

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