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Blood, 15 February 2008, Vol. 111, No. 4, pp. 1848-1854. Prepublished online as a Blood First Edition Paper on December 14, 2007; DOI 10.1182/blood-2007-07-099317. This Article Full Text Full Text (PDF) All Versions of this Article: blood-2007-07-099317v1 blood-2007-07-099317v2 111/4/1848    most recent Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Bartlett, N. L. Articles by Barton, J. Search for Related Content PubMed PubMed Citation Articles by Bartlett, N. L. Articles by Barton, J. Related Collections Clinical Trials and Observations Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  CLINICAL TRIALS AND OBSERVATIONS A phase 1 multidose study of SGN-30 immunotherapy in patients with refractory or recurrent CD30+ hematologic malignancies Nancy L. Bartlett1, Anas Younes2, Matthew H. Carabasi3, Andres Forero4, Joseph D. Rosenblatt5, John P. Leonard6, Steven H. Bernstein7, R. Gregory Bociek8, Jennie M. Lorenz9, Bruce W. Hart9, and Jeremy Barton9 1 Washington University, St Louis, MO; 2 M. D. Anderson Cancer Center, Houston, TX; 3 Norris Cancer Center, Los Angeles, CA; 4 University of Alabama, Birmingham; 5 Sylvester Cancer Center, Miami, FL; 6 Cornell University, New York, NY; 7 University of Rochester, Rochester, NY; 8 University of Nebraska Medical Center, Omaha, NE; and 9 Seattle Genetics, Seattle, WA Phase 1 testing of SGN-30, a chimeric monoclonal antibody for the treatment of CD30+ malignancies, was conducted in a multicenter study. To explore the safety profile and establish the maximum tolerated dose (MTD), 24 patients with refractory or relapsed Hodgkin lymphoma or CD30+ non-Hodgkin lymphoma received 6 weekly doses of intravenous SGN-30 at 4 dose levels (2, 4, 8, or 12 mg/kg). Serum concentrations of SGN-30 rose rapidly and were dose dependent. Adverse events were mild, with nausea, fatigue, and fever attributed to study treatment. One episode of hypersensitivity rash was reported. The MTD was not reached. Serious adverse events included herpes zoster (n = 2), influenza, and pneumonia. One patient with cutaneous anaplastic large cell lymphoma (8 mg/kg) achieved a complete response. Six patients, of whom 4 had Hodgkin lymphoma, achieved stable disease with durations ranging from 6 to 16 months. The pharmacokinetic profile of SGN-30 showed a biphasic disposition, and estimated half-lives ranging between 1 to 3 weeks. The 6 weekly infusions of SGN-30 resulted in approximately 2- to 3-fold accumulation in serum exposures consistently across the dose range. These results demonstrate that weekly administration of SGN-30 is safe and has modest clinical activity in patients with CD30+ tumors. This trial is registered at http://www.ClinicalTrials.gov as no. NCT00051597 [ClinicalTrials.gov] . CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: B. Falini and M. P. Martelli Anaplastic large cell lymphoma: changes in the World Health Organization classification and perspectives for targeted therapy Haematologica, July 1, 2009; 94(7): 897 - 900. [Full Text] [PDF] A. K. Gopal, J. M. Pagel, J. R. Fromm, S. Wilbur, and O. W. Press 131I anti-CD45 radioimmunotherapy effectively targets and treats T-cell non-Hodgkin lymphoma Blood, June 4, 2009; 113(23): 5905 - 5910. [Abstract] [Full Text] [PDF] P. M. Cardarelli, M.-C. Moldovan-Loomis, B. Preston, A. Black, D. Passmore, T.-H. Chen, S. Chen, J. Liu, M. R. Kuhne, M. Srinivasan, et al. In vitro and In vivo Characterization of MDX-1401 for Therapy of Malignant Lymphoma Clin. Cancer Res., May 15, 2009; 15(10): 3376 - 3383. [Abstract] [Full Text] [PDF] B. Pro Novel Agents in Peripheral T-cell Lymphomas ASCO Educational Book, January 1, 2009; 2009(1): 486 - 489. [Abstract] [Full Text] [PDF]

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