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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.
 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]
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