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Blood, 1 July 2004, Vol. 104, No. 1, pp. 227-236. Prepublished online as a Blood First Edition Paper on March 2, 2004; DOI 10.1182/blood-2003-09-3284. This Article Full Text Full Text (PDF) All Versions of this Article: 2003-09-3284v1 104/1/227    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 Forero, A. Articles by Meredith, R. F. Search for Related Content PubMed PubMed Citation Articles by Forero, A. Articles by Meredith, R. F. Related Collections Immunobiology Neoplasia Immunotherapy Clinical Trials and Observations Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  NEOPLASIA Phase 1 trial of a novel anti-CD20 fusion protein in pretargeted radioimmunotherapy for B-cell non-Hodgkin lymphoma Andres Forero, Paul L. Weiden, Julie M. Vose, Susan J. Knox, Albert F. LoBuglio, Jordan Hankins, Michael L. Goris, Vincent J. Picozzi, Don B. Axworthy, Hazel B. Breitz, Robert B. Sims, Richard G. Ghalie, Sui Shen, and Ruby F. Meredith From the University of Alabama at Birmingham Comprehensive Cancer Center; Stanford University Medical Center, Palo Alto, CA; University of Nebraska Medical Center, Omaha; Virginia Mason Medical Center, Seattle WA; and NeoRx Corporation, Seattle, WA. Pretargeted radioimmunotherapy (PRIT) has the potential to increase the dose of radionuclide delivered to tumors while limiting radiation to normal tissues. The purpose of this phase 1 trial is to assess safety of this multistep approach using a novel tetrameric single-chain anti-CD20–streptavidin fusion protein (B9E9FP) as the targeting moiety in patients with B-cell non-Hodgkin lymphoma (NHL), and to characterize its pharmacokinetics and immunogenicity. All patients received B9E9FP (160 mg/m2 or 320 mg/m2); either 48 or 72 hours later, a synthetic clearing agent (sCA) was administered (45 mg/m2) to remove circulating unbound B9E9FP. 90Yttrium (90Y; 15 mCi/m2)/111In (5 mCi)–DOTA-biotin was injected 24 hours later. There were 15 patients enrolled in the study. B9E9FP had a mean plasma half-life (T) of 25 ± 6 hours with a reduction in plasma level of more than 95% within 6 hours of sCA administration. 90Y/111In-DOTA-biotin infusion resulted in rapid tumor localization and urinary excretion. The ratio of average tumor to whole-body radiation dose was 49:1. No significant hematologic toxicities were noted in 12 patients. There were 2 patients who had hematologic toxicity related to progressive disease. There were 2 complete remissions (90 and 325 days) and one partial response (297 days). B9E9FP performs well as the targeting component of PRIT with encouraging dosimetry, safety, and efficacy. A dose escalation trial of 90Y-DOTA-biotin in this format is warranted. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: R. M. Sharkey, H. Karacay, S. Litwin, E. A. Rossi, W. J. McBride, C.-H. Chang, and D. M. Goldenberg Improved Therapeutic Results by Pretargeted Radioimmunotherapy of Non-Hodgkin's Lymphoma with a New Recombinant, Trivalent, Anti-CD20, Bispecific Antibody Cancer Res., July 1, 2008; 68(13): 5282 - 5290. [Abstract] [Full Text] [PDF] F. Buchegger, O. W. Press, A. B. Delaloye, and N. Ketterer Radiolabeled and Native Antibodies and the Prospect of Cure of Follicular Lymphoma Oncologist, June 1, 2008; 13(6): 657 - 667. 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