Oncolytic Adenovirus-Mediated Gene Therapy for Lung Cancer

Summary

The primary objective of this phase 1 trial is to determine the dose-dependent toxicity and maximum tolerated dose (MTD) of oncolytic adenovirus-mediated cytotoxic gene therapy in combination with SBRT in medically inoperable stage I/IIA (T1A - T2B) NSCLC. To accomplish this objective, 9 subjects will be enrolled in the study. We hypothesize that the combined treatment will demonstrate acceptable toxicity, and that it will be feasible to quantify adenovirus-mediated HSV-1 TK gene expression in the lung by PET. This phase 1 trial will lay the foundation for a follow-up phase 2 trial designed to examine efficacy.

Timeline

Start

2017-01-13

Primary completion

2018-12-31

Completion

2022-12-31

Outcome

Outcome not reported

Stopped (Enrollment): “No participants were enrolled”

Drugs

Indications