Phase 1 Study of A Virus-based Gene Therapy for Non-small Cell Lung Cancer

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Researchers are evaluating whether Ad5-yCD/mutTKSR39rep-ADP, an oncolytic adenovirus, can help to improve outcomes among patients with inoperable stage I/IIA NSCLC.
Researchers are evaluating whether Ad5-yCD/mutTKSR39rep-ADP, an oncolytic adenovirus, can help to improve outcomes among patients with inoperable stage I/IIA NSCLC.

Title: Phase 1 Trial of Oncolytic Adenovirus-Mediated Cytotoxic Gene Therapy in Combination With Stereotactic Body Radiation Therapy (SBRT) in Clinical Stage 1/11A (T1A-T2B) Non-Small Cell Lung Cancer1

Principal Investigators: Benjamin Movsas, MD, Chair, Henry Ford Health System

Description: For this open-label phase 1 trial (ClinicalTrials.gov Identifier: NCT03029871), researchers are evaluating whether Ad5-yCD/mutTKSR39rep-ADP, an oncolytic adenovirus, can help to improve outcomes among patients with inoperable stage I/IIA non–small cell lung cancer (NSCLC).

All patients will receive the adenovirus by injection at 1 of 3 doses: (1 x 1011 vp, 3 x 1011 vp, or 1 x 1012 vp). Patients will also receive 5-fluorocytosine, valganciclovir, and SBRT.

The primary study endpoint is toxicity; secondary outcomes include tumor response, progression-free survival, overall survival, and quality of life. Researchers will also measure HSV-1 TK expression using PET imaging.

The estimated study enrollment is 9 patients.

For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT03029871.

Status: This study is open and recruiting patients as of December 14, 2017.

This study is sponsored by Benjamin Movsas, MD.

Reference

  1. Clinicaltrials.gov. Oncolytic adenovirus-mediated gene therapy for lung cancer (NSCLC).  NCT03029871. https://clinicaltrials.gov/ct2/show/NCT03029871. Accessed December 14, 2017.

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