A phase 1 multidose 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, Robert G Bociek, Jennie M. Lorenz, Bruce W. Hart, Jeremy Barton

Research output: Contribution to journalArticle

140 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1848-1854
Number of pages7
JournalBlood
Volume111
Issue number4
DOIs
StatePublished - Feb 15 2008

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Pharmacokinetics
Hematologic Neoplasms
Refractory materials
Immunotherapy
Tumors
Monoclonal Antibodies
Fatigue of materials
Maximum Tolerated Dose
Testing
Hodgkin Disease
Anaplastic Large-Cell Lymphoma
Herpes Zoster
Exanthema
Serum
Non-Hodgkin's Lymphoma
Nausea
Human Influenza
Multicenter Studies
Fatigue
Neoplasms

ASJC Scopus subject areas

  • Biochemistry
  • Immunology
  • Hematology
  • Cell Biology

Cite this

Bartlett, N. L., Younes, A., Carabasi, M. H., Forero, A., Rosenblatt, J. D., Leonard, J. P., ... Barton, J. (2008). A phase 1 multidose study of SGN-30 immunotherapy in patients with refractory or recurrent CD30+ hematologic malignancies. Blood, 111(4), 1848-1854. https://doi.org/10.1182/blood-2007-07-099317

A phase 1 multidose study of SGN-30 immunotherapy in patients with refractory or recurrent CD30+ hematologic malignancies. / Bartlett, Nancy L.; Younes, Anas; Carabasi, Matthew H.; Forero, Andres; Rosenblatt, Joseph D.; Leonard, John P.; Bernstein, Steven H.; Bociek, Robert G; Lorenz, Jennie M.; Hart, Bruce W.; Barton, Jeremy.

In: Blood, Vol. 111, No. 4, 15.02.2008, p. 1848-1854.

Research output: Contribution to journalArticle

Bartlett, NL, Younes, A, Carabasi, MH, Forero, A, Rosenblatt, JD, Leonard, JP, Bernstein, SH, Bociek, RG, Lorenz, JM, Hart, BW & Barton, J 2008, 'A phase 1 multidose study of SGN-30 immunotherapy in patients with refractory or recurrent CD30+ hematologic malignancies', Blood, vol. 111, no. 4, pp. 1848-1854. https://doi.org/10.1182/blood-2007-07-099317
Bartlett, Nancy L. ; Younes, Anas ; Carabasi, Matthew H. ; Forero, Andres ; Rosenblatt, Joseph D. ; Leonard, John P. ; Bernstein, Steven H. ; Bociek, Robert G ; Lorenz, Jennie M. ; Hart, Bruce W. ; Barton, Jeremy. / A phase 1 multidose study of SGN-30 immunotherapy in patients with refractory or recurrent CD30+ hematologic malignancies. In: Blood. 2008 ; Vol. 111, No. 4. pp. 1848-1854.
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