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Annals of Oncology 13:777-780, 2002
© 2002 European Society for Medical Oncology

Original Paper

Phase II study of XR5000 (DACA) administered as a 120-h infusion in patients with recurrent glioblastoma multiforme

C. Twelves1,+, M. Campone2, B. Coudert3, M. Van den Bent4, M. de Jonge4, C. Dittrich5, R. Rampling1, R. Sorio6, D. Lacombe7, C. de Balincourt7 and P. Fumoleau2

1Cancer Research UK, Department of Medical Oncology and Beatson Oncology Centre, Glasgow, UK; 2Centre Rene Gauducheau, Nantes, France; 3Centre G.F. Leclerc, Dijon, France; 4Rotterdam Cancer Institute (Daniel den Hoed Kliniek) and University Hospital Rotterdam, The Netherlands; 5Kaiser Franz Josef Spital, Vienna, Austria; 6Centre di Referimento Oncologico, Aviano, Italy; 7European Organisation for Research and Treatment of Cancer Data Centre, Brussels, Belgium

Received 10 September 2001; revised 30 October 2001; accepted 16 November 2001 .

Background

XR5000 is a tricyclic carboxamide that intercalates DNA and inhibits both topoisomerase I and II. The aim of this study was to evaluate the efficacy and tolerability of XR5000 in patients with recurrent glioblastoma multiforme previously untreated with chemotherapy at relapse.

Patients and methods

Patients received XR5000 at a dose of 3010 mg/m2 as a 120-h central venous infusion every 3 weeks. An independent panel assessed response every two cycles using McDonald’s criteria (tumour size, steroid intake and neurological status); toxicity was graded according to the National Cancer Institute-Common Toxicity Criteria, version 2.0.

Results

Sixteen patients were enrolled (one ineligible patient was excluded from efficacy evaluation). Performance status was zero (five patients), one (nine patients) or two (one patient). They received 30 cycles of XR5000 (median 2, range 1–5). Haematological toxicity was mild, with only one patient experiencing grade 3 neutropenia. Other related grade 3/4 adverse events included chest pain (one patient), axillary vein thrombosis (one patient) and rigors/fever in the absence of neutropenia (one patient). There were no objective responses, 14 patients progressing on XR5000 and one having stable disease.

Conclusions

Although XR5000 was generally well tolerated, these results do not support further evaluation in patients with glioblastoma multiforme using this dose and schedule.

Key words: chemotherapy, glioblastoma multiforme, phase II


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