Clinical Trial: Vaccine Treatment for Advanced Non-Small Cell Lung Cancer
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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 No
Brief Summary:
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:
- Background:
- Lung cancer remains the leading cause of cancer death with an estimated 174,400 new cases and 162,400 deaths each year in the U.S.
- Despite attempts at early diagnosis and the development of new therapeutic agents, there has been only limited improvement in the outcome for patients with advanced lung cancer.
- A enzyme called alpha(1,3)galactosyltranferase (alphaGT) that is not found in humans can transfer sugars on to proteins in human cells that can make them highly immunogenic and cause them to be rejected by the body.
- Antitumor vaccination using killed donor human lung cancer cells expressing alphaGT may stimulate immune responses in patients against their own lung cancer because their lung cancer may share antigens with the vaccine cells that have been made more immunogenic by expression of alphaGT.
- To assess the tumor response rate of anti-tumor vaccination using irradiated allogeneic lung cancer cell lines genetically engineered to express the murine alpha(1,3)galactosyltransferase enzyme in patients with advanced, recurrent or refractory non-small cell lung cancer.
- To assess the immunological response of patients with lung cancer undergoing antitumor vaccination with irradiated allogeneic lung cancer cell lines genetically engineered to express murine alpha(1,3)galactosyltransferase.
- Assess the survival distribution as well as the duration of response.
Objectives:
Phase I has been completed.
Phase II
Current Primary Outcome: Safety and response rate [ Time Frame: Days 57, 85, 127 ]
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: NewLink Genetics Corporation
Dates:
Date Received: November 19, 2003
Date Started: November 2003
Date Completion:
Last Updated: June 25, 2015
Last Verified: June 2015
