Oncolytic Adenovirus-Mediated Gene Therapy for Lung Cancer (NSCLC)
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 Cancer
Doctors at the Henry Ford Health System are investigating a treatment for medically inoperable non-small cell lung cancer. The therapy involves a single injection of a genetically engineered adenovirus to target and infect cancer cells, transferring to them a cancer suicide gene called HSV-tK to their tumor. In combination with valganciclovir (vGCV), a prodrug therapy, this gene may cause the cancer to self-detonate by incorporating a molecule that stops their replication. This experimental treatment will be delivered along with standard radiation and chemotherapy.
Follow up will be required twice a week for the first 2 weeks and then at scheduled follow-up visits through 60 months.
- Be 18 years of age or older
- Have a diagnosis of NSCLC meeting clinical criteria for staging and size
- Must agree to contraception for at least 2 months after the gene therapy
- Not have received chemotherapy for the cancer being treated
THE STUDY INVOLVES:
- Prescreening tests to confirm eligibility of the patient to participate.
- Depending on the location of the target lesion, the therapy will be injected either transbronchially (central tumors) or through the skin with help of imaging to guide it.
- Two days later, subjects will be administered (orally) a 10 day course of chemotherapy and valganciclovir (vGCV) prodrug therapy along with Stereotactic Body Radiation Therapy.
- Prior to and following the adenovirus injection, subjects will be given a will undergo PET imaging, after receiving a radiotracer, to quantify the desired suicide gene expression.
- Toxicity assessments will occur twice a week for the first 2 weeks and then at scheduled follow-up visits through 60 months.
LOCATIONS AND CONTACTS:
The study site is at Henry Ford Health System in Detroit, MI. Map.
Benjamin Movsas, M.D.
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