Phase I Study of IV DOTAP: Cholesterol-Fus1 in Non-Small-Cell Lung Cancer

Summary

The goal of this clinical research study is to find out the highest safe dose of DOTAP:Chol-fus1 that can be given to participants in the treatment of non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC). This study is an attempt to transfer a gene (fus1) into cancer cells, using the drug DOTAP:Cholesterol-fus1. Researchers will also study the side effects of this experimental gene transfer at different doses, and will conduct tests to see if there are any effects on tumor size at different doses. Experimental transfer of the fus1 gene into humans has never been tried before. Objectives: * Assess the toxicity of DOTAP:Cholesterol-fus1 Liposome Complex (DOTAP:Chol-fus1) administered intravenously. * To determine the maximal tolerated dose and recommended phase II dose of DOTAP:Chol-fus1 administered intravenously. * Assess the expression of fus1 following intravenous delivery of DOTAP:Chol-fus1 in tumor and normal bronchial epithelial cell biopsies. * Assess any anti-cancer activity for DOTAP:Chol-fus1.

Timeline

Start

2003-03

Primary completion

2011-04

Completion

2011-04

Publications

• Lu C, Stewart DJ, Lee JJ, Ji L, Ramesh R, Jayachandran G, Nunez MI, Wistuba II, Erasmus JJ, Hicks ME, Grimm EA, Reuben JM, Baladandayuthapani V, Templeton NS, McMannis JD, Roth JA. Phase I clinical trial of systemically administered TUSC2(FUS1)-nanoparticles mediating functional gene transfer in humans. PLoS One. 2012;7(4):e34833. doi: 10.1371/journal.pone.0034833. Epub 2012 Apr 25.

Drugs

Indications