A Phase I/II Study of Tergenpumatucel-L (HyperAcute Lung) an Antitumor Vaccination Using Alpha (1,3) Galactosyltransferase Expressing Allogeneic Tumor Cells in Patients With Refractory or Recurrent Non-Small Cell Lung Cancer

This 2-phase study will determine the safety of treating patients with non-small cell lung cancer with the genetically engineered HyperAcute-Lung cancer vaccine. It will establish the proper vaccine dose and will examine side effects and potential benefits of the treatment. The vaccine contains killed lung cancer cells containing a mouse gene that causes the production of a foreign pattern of protein-sugars on the cell surface. It is hoped that the immune response to the foreign substance will stimulate the immune system to attack the patient's own cancer cells that have similar proteins without this sugar pattern, causing the tumor to remain stable or shrink.

Patients 18 years of age or older with non-small cell lung cancer that has recurred or no longer responds to standard treatment may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood tests, urinalysis, chest x-rays, and lung function testing. CT, MRI, PET, and ultrasound scans of the chest may be obtained if needed.

Participants will receive four vaccinations a month apart from each other. The vaccines will be injected under the skin, similar to the way a tuberculosis skin test is given. Phase I of the study will treat successive groups of patients with increasing numbers of the vaccine cells to evaluate side effects of the treatment and determine the optimum dose. Phase II will look for any beneficial effects of the vaccine given at the highest dose found to be safe in Phase I. Weekly blood samples will be drawn during the 4 months of vaccine treatment. In addition, patient follow-up visits will be scheduled every 2 months for the first year after vaccination and then every 3 months for the next 2 years for the following tests and procedures to evaluate treatment response and side effects:

• Medical history and physical examination
• Blood tests
• X-rays and various scans (nuclear medicine/CT/MRI)
• FACT-L Assessment questionnaire to measure the impact of treatment on the patient's general well-being. The questionnaire is administered before beginning treatment, before each vaccination, and during follow-up visits after completing the treatment. It includes questions on the severity of lung cancer symptoms and the ability to perform normal activities of daily life.

In addition to the above procedures, 3 skin punch biopsies will be done at the vaccination site to look for a local immune response. For this procedure, an area of skin is numbed with an anesthetic and a 4 mm (about 1/4-inch) circular area is removed, using a sharp cookie cutter-type instrument. Also, one blood sample per year will be collected for the next 15 years to monitor the safety of the gene transfer. Patients whose lung cancer spreads to the skin, superficial soft tissues, or a superficial lymph node may be asked to undergo a biopsy of the lesion to see what effect the treatment may be having on the tumor.