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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 13, 2007December 14, 2007; DOI 10.1182/blood-2007-07-099317.
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Submitted July 6, 2007
Accepted November 24, 2007
A phase 1 multi-dose study of SGN-30 immunotherapy in patients with refractory or recurrent CD30+ hematologic malignancies
Nancy L. Bartlett*, Anas Younes, Matthew H. Carabasi, Andres Forero, Joseph D. Rosenblatt, John P. Leonard, Steven H. Bernstein, R. Gregory Bociek, Jennie M. Lorenz, Bruce W. Hart, and Jeremy Barton
Internal Medicine, Medical Oncology, Washington University School of Medicine, St. Louis, MO, United States
Internal Medicine, Lymphoma/Myeloma, M. D. Anderson Cancer Center, Houston, TX, United States
Internal Medicine, Medical Oncology, Norris Cancer Center, Los Angeles, CA, United States
Internal Medicine, Medical Oncology, Univeristy of Alabama, Birmingham, AL, United States
Internal Medicine, Medical Oncology, Sylvester Cancer Center, Miami, Florida, United States
Internal Medicine, Medical Oncology, Cornell University, New York City, NY, United States
Internal Medicine, Medical Oncology, University of Rochester, Rochester, NY, United States
Internal Medicine, Medical Oncology, University of Nebraska Medical Center, Omaha, NE, United States
Seattle Genetics, Inc., Bothell, WA, United States
* Corresponding author; email: nbartlet{at}im.wustl.edu.
Phase I 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 positive non-Hodgkin lymphoma received 6 weekly doses of intravenous SGN-30 at four 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 1-3 weeks. The six weekly infusions of SGN-30 resulted in approximately 2-3 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-positive tumors. This trial is registered at www.ClinicalTrials.gov
as #NCT00051597.
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