A phase II study of SGN-30 in cutaneous anaplastic large cell lymphoma and related lymphoproliferative disorders.

Abstract

PURPOSE:

An open-label, multicenter, phase II study was conducted to define the safety and antitumor activity of the monoclonal antibody SGN-30 in patients with CD30(+) primary cutaneous anaplastic large cell lymphoma (pc-ALCL), lymphomatoid papulosis (LyP), or transformed mycosis fungoides (T-MF).

EXPERIMENTAL DESIGN:

In the initial course (six doses), patients received i.v. SGN-30 every 3 weeks; eligible patients could receive two additional courses. The initial dose level of 4 mg/kg was increased to 12 mg/kg by protocol amendment.

RESULTS:

The overall objective response rate [complete response (CR) + partial response (PR)] was 70% (16 of 23 patients): 10 patients achieved a CR and another 6 patients achieved a PR. Overall, clinical benefit of SGN-30, as assessed by achieving a response to therapy or stable disease (CR + PR + stable disease), was shown by 87% of patients during the study, including all patients with pc-ALCL or LyP and two thirds of patients with T-MF or with multiple clinical diagnoses. Nine of the 10 patients who achieved a CR and 5 of the 6 patients who achieved a PR were in remission at their follow-up evaluation (median duration, 84 days). Fifteen of 23 patients (65%) experienced at least one adverse event during the study, most of which were mild or moderate.

CONCLUSIONS:

SGN-30 was clinically active in 16 of 23 patients with heavily pretreated pc-ALCL, LyP, and T-MF and was well tolerated in this study.

• Authors: Madeleine Duvic, Sunil A Reddy, Lauren Pinter-Brown, Neil J Korman, John Zic, Dana A Kennedy, Jennie Lorenz, Eric L Sievers, Youn H Kim
• Journal: Clinical cancer research : an official journal of the American Association for Cancer Research (Clin Cancer Res) Vol. 15 Issue 19 Pg. 6217-24 (Oct 01 2009) ISSN: 1557-3265 [Electronic] United States
• PMID: 19789316 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal
• Antineoplastic Agents
• SGN-30 monoclonal antibody

Topics

• Adult
• Aged
• Algorithms
• Antibodies, Monoclonal (administration & dosage, adverse effects, therapeutic use)
• Antineoplastic Agents (administration & dosage, adverse effects, therapeutic use)
• Dose-Response Relationship, Drug
• Female
• Humans
• Immunotherapy (methods)
• Lymphoma, Large-Cell, Anaplastic (mortality, therapy)
• Lymphoproliferative Disorders (mortality, therapy)
• Male
• Middle Aged
• Skin Neoplasms (mortality, therapy)
• Survival Analysis
• Time Factors
• Treatment Outcome