Phase II study of XR5000 (DACA) administered as a 120-h infusion in patients with recurrent glioblastoma multiforme
| Autor: | Pierre Fumoleau, Mario Campone, Chris Twelves, Denis Lacombe, M. J. van den Bent, Roy Rampling, Bruno Coudert, C. de Balincourt, M.J.A. de Jonge, C. Dittrich, Roberto Sorio |
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| Přispěvatelé: | Neurology, Medical Oncology |
| Rok vydání: | 2002 |
| Předmět: |
Adult
Male medicine.medical_specialty medicine.medical_treatment Phases of clinical research Neutropenia Chest pain Drug Administration Schedule Internal medicine medicine Humans Infusions Intravenous Adverse effect Aged Neoplasm Staging Chemotherapy Dose-Response Relationship Drug Performance status Brain Neoplasms business.industry Hematology Middle Aged medicine.disease Survival Analysis Surgery Treatment Outcome Oncology Tolerability Toxicity Acridines Female Neoplasm Recurrence Local medicine.symptom Glioblastoma business Follow-Up Studies |
| Zdroj: | Annals of Oncology, 13, 777-780. Elsevier Ltd. |
| ISSN: | 0923-7534 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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