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Clinical Cancer Research Vol. 6, 1632-1638, May 2000
© 2000 American Association for Cancer Research


Advances in Brief

A Phase I Trial of a Recombinant Vaccinia Virus Expressing Prostate-specific Antigen in Advanced Prostate Cancer1

Joseph Paul Eder2, Philip W. Kantoff, Kristin Roper, GuangXian Xu, Glenn J. Bubley, John Boyden, Linda Gritz, Gail Mazzara, William K. Oh, Philip Arlen, Kwong Y. Tsang, Dennis Panicali, Jeffrey Schlom and Donald W. Kufe

Division of Adult Oncology, Dana-Farber Cancer Institute, Department of Medicine, Brigham and Women’s Hospital, Boston, Massachusetts 02115 [J. P. E., P. W. K., K. R., G. X., J. B., W. K. O., D. W. K.]; Division of Hematology/Oncology, Department of Medicine, Beth Israel Deaconess Medical Center; Dana-Farber/Harvard Cancer Center, Harvard Medical School, Boston, Massachusetts 02115 [J. P. E., G. J. B.]; National Cancer Institute, NIH, Bethesda, Maryland 20892 [P. A., K. Y. T., J. S.]; and Therion Biologics Corporation, Cambridge, Massachusetts 02142 [L. G., G. M., D. P.]

A recombinant vaccinia virus encoding human prostate-specific antigen (rV-PSA) was administered as three consecutive monthly doses to 33 men with rising PSA levels after radical prostatectomy, radiation therapy, both, or metastatic disease at presentation. Dose levels were 2.65 x 106, 2.65 x 107, and 2.65 x 108 plaque forming units. Ten patients who received the highest dose also received 250 µg/m2 granulocyte-macrophage colony-stimulating factor (GM-CSF) as an immunostimulatory adjunct. No patient experienced any virus-related effects beyond grade I cutaneous toxicity. Pustule formation and/or erythema occurred after the first dose in all 27 men who received >=2.65 x 107 plaque forming units. GM-CSF administration was associated with fevers and myalgias of grade 2 or lower in 9 of 10 patients. PSA levels in 14 of 33 men treated with rV-PSA with or without GM-CSF were stable for at least 6 months after primary immunization. Nine patients remained stable for 11–25 months; six of these remain progression free with stable PSA levels. Immunological studies demonstrated a specific T-cell response to PSA-3, a 9-mer peptide derived from PSA. rV-PSA is safe and can elicit clinical and immune responses, and certain patients remain without evidence of clinical progression for up to 21 months or longer.




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HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
Cancer Research Clinical Cancer Research
Cancer Epidemiology Biomarkers & Prevention Molecular Cancer Therapeutics
Molecular Cancer Research Cancer Prevention Research
Cancer Prevention Journals Portal Cancer Reviews Online
Annual Meeting Education Book Meeting Abstracts Online
Copyright © 2000 by the American Association for Cancer Research.