Phase 1 Study of A Virus-based Gene Therapy for Non-small Cell Lung Cancer
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.
- Clinicaltrials.gov. Oncolytic adenovirus-mediated gene therapy for lung cancer (NSCLC). NCT03029871. https://clinicaltrials.gov/ct2/show/NCT03029871. Accessed December 14, 2017.