Intratumoral Gene Mediated Cytotoxic Immunotherapy in Patients With Resectable Non-Small Cell Lung Cancer
University of Pennsylvania researchers seek participants in a clinical investigation of a genetic therapy in combination with standard surgery for non-small cell lung cancer. The investigational therapy is a genetically engineered adenovirus to infect tumor cells and transfer to their DNA a specific gene. When the tumor cells express the gene, they will become sensitive to a prodrug called valacyclovir, which will kill the tumor cells. This tumor cell death may also stimulate the body’s immune cells to attack the tumor. Researchers hope these genes, transferred by the virus, will lead patients’ immune systems to slow or reverse the growth of their tumors.
The steps involve an injection of the virus to the tumor, followed by 14 days of the prodrug, with surgery following another week later. Chemotherapy and/or radiation can be scheduled 6 to 8 weeks after surgery.
- Be 18 years of age or older
- Pathologically documented non-small cell carcinoma
- The tumor must be 4cm or greater in diameter based on imaging
- Not be pregnant or breastfeeding
- Known sensitivity or allergic reactions to valacyclovir
THE STUDY INVOLVES:
- Prescreening tests to confirm eligibility of the patient to participate.
- Injection of the investigational drug directly to the tumor
- 14 days of valacyclovir prodrug, administered orally
- Surgical resection of the tumor ~ 3 weeks after step (2)
- Chemotherapy or radiation, as directed by the oncologist, may begin 6 to 8 weeks after surgery
- Follow up will continue at 6 weeks, 12 months, and 5 years.
LOCATIONS AND CONTACTS:
The study site is at the University of Pennsylvania. Map.
Contacts: Brenda Horn | [email protected] | 215-590-4202
University of Pennsylvania
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