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Originally published as JCO Early Release 10.1200/JCO.2005.05.5335 on September 11 2006 © 2006 American Society of Clinical Oncology. Phase II Study of Belagenpumatucel-L, a Transforming Growth Factor Beta-2 Antisense Gene-Modified Allogeneic Tumor Cell Vaccine in NonSmall-Cell Lung Cancer
From the Mary Crowley Medical Research Center/Texas Oncology Professional Association; Baylor Sammons Cancer Center, Baylor University Medical Center; Murex Pharmaceutical Inc; Institute for Health Care Research and Improvement, Baylor Health Care System, Dallas, TX; Hoag Cancer Center, Newport Beach; NovaRx Corporation, San Diego, CA; and Louisiana State University, New Orleans, LA Address reprint requests to John Nemunaitis, MD, 1717 Main St, 60th Floor, Dallas, TX 75201; e-mail: jnemunaitis{at}mcmrc.com PURPOSE: Belagenpumatucel-L is a nonviral gene-based allogeneic tumor cell vaccine that demonstrates enhancement of tumor antigen recognition as a result of transforming growth factor beta-2 inhibition. PATIENTS AND METHODS: We performed a randomized, dose-variable, phase II trial involving stages II, IIIA, IIIB, and IV nonsmall-cell lung cancer patients. Each patient received one of three doses (1.25, 2.5, or 5.0 x 107 cells/injection) of belagenpumatucel-L on a monthly or every other month schedule to a maximum of 16 injections. Immune function, safety, and anticancer activity were monitored.
RESULTS: Seventy-five patients (two stage II, 12 stage IIIA, 15 stage IIIB, and 46 stage IV patients) received a total of 550 vaccinations. No significant adverse events were observed. A dose-related survival difference was demonstrated in patients who received CONCLUSION: Belagenpumatucel-L is well tolerated, and the survival advantage justifies further phase III evaluation. published online ahead of print at www.jco.org on September 11, 2006. Supported in part by Small Business Innovative Research Grant No. 1 R44 CA96025 (H.F.). Terms in blue are defined in the glossary, found at the end of this article and online at www.jco.org. Authors disclosures of potential conflicts of interest and author contributions are found at the end of this article. This article has been cited by other articles:
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Copyright © 2006 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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