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


METHODS
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.
Duvic
Madeleine
M
Department of Dermatology, University of Texas MD Anderson Cancer Center, Houston, Texas 77030-4003, USA.
Reddy
Sunil A
SA
Pinter-Brown
Lauren
L
Korman
Neil J
NJ
Zic
John
J
Kennedy
Dana A
DA
Lorenz
Jennie
J
Sievers
Eric L
EL
Kim
Youn H
YH
D000328:Adult; D000368:Aged; D000465:Algorithms; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007167:Immunotherapy / Q000379:methods; D017728:Lymphoma, Large-Cell, Anaplastic / Q000401:mortality / Q000628:therapy*; D008232:Lymphoproliferative Disorders / Q000401:mortality / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D012878:Skin Neoplasms / Q000401:mortality / Q000628:therapy*; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D000970:Antineoplastic Agents; C504717:SGN-30 monoclonal antibody