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Annals of Oncology 2004 15(9):1413-1418; doi:10.1093/annonc/mdh359
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© 2004 European Society for Medical Oncology

Original Article

Phase II study of ISIS 3521, an antisense oligodeoxynucleotide to protein kinase C alpha, in patients with previously treated low-grade non-Hodgkin's lymphoma

S. Rao1, D. Watkins1, D. Cunningham1,*, D. Dunlop2, P. Johnson3, P. Selby4, B. W. Hancock5, C. Fegan6, D. Culligan7, S. Schey8, T. C. M. Morris9, T. Lissitchkov10, J. W. Oliver11 and J. T. Holmlund11

1 Royal Marsden Hospital, London and Surrey; 2 St Mungo Institute, Glasgow; 3 Southampton Hospitals NHS Trust, Southampton; 4 St James University Hospital, Leeds; 5 Weston Park Hospital NHS Trust, Sheffield; 6 Birmingham Heartlands Hospital, London; 7 Aberdeen Royal Infirmary, Aberdeen; 8 Guy's Hospital, London; 9 Belfast City Hospital, Belfast, UK; 10 National Institute of Haematology and Transfusiology, Sofia, Bulgaria; 11 ISIS Pharmaceuticals, Inc., Carlsbad, CA, USA

* Correspondence to:Professor D. Cunningham, Department of Medicine, Royal Marsden Hospital, Downs Road, Sutton, Surrey SM2 5PT, UK. Tel: +44-20-8661-3156; Fax: +44-20-8643-9414; Email: dcunn{at}icr.ac.uk

Background: The purpose of this study was to assess the efficacy and safety of ISIS 3521, an antisense phosphorothioate oligonucleotide to protein kinase C {alpha} in patients with relapsed low-grade non-Hodgkin's lymphoma (NHL).

Patients and methods: Twenty-six patients received ISIS 3521 (2 mg/kg/day) as a continuous infusion over 21 days of each 28-day cycle.

Results: The median age of the patients was 53 years (range 37–77). Histological subtypes were low-grade follicular lymphoma (n=22) and B-cell small lymphocytic lymphoma (n=4). Twenty-one (81%) had stage III/IV disease. The median number of previous lines of chemotherapy was two (range one to six). A total of 87 cycles of ISIS 3521 were administered. Twenty-three patients were assessable for response. Three patients achieved a partial response. No complete responses were observed. Ten patients had stable disease. Grade 3–4 toxicity was as follows: neutropenia (3.8%) and thrombocytopenia (26.9%).

Conclusions: ISIS 3521 has demonstrated anti-tumour activity in patients with relapsed low-grade NHL. There may be a potential role for this agent in combination with conventional chemotherapy for advanced low-grade lymphoma, and further trials are warranted.

Key words: antisense, follicular, non-Hodgkin's lymphoma, treatment


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