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Annals of Oncology 7:205-207, 1996
© 1996 European Society for Medical Oncology

other

Phase II study of topotecan in patients with recurrent malignant glioma

D. Macdonald1,2,3, G. Cairncross1,2,3, D. Stewart4,5, P. Forsyth6,7, C. Sawka8,9, N. Wainman10, E. Eisenhauer10 and National Clinical Institute of Canada Clinical Trials Group (NCIC CTG)

1Departments of Clinical Neurological Sciences London
2Departments of Oncology, University of Western Ontario London
3Departments of London Regional Cancer Centre London
4Department of Medicine, University of Ottawa Ottawa, Ontario
5Ottawa Regional Cancer Centre Ottawa, Ontario
6Department of Clinical Neurosciences, University of Calgary Calgary, Alberta
7Tom Baker Cancer Centre Calgary, Alberta
8Department of Medicine, University of Toronto Toronto
9Toronto-Sunnybrook Regional Cancer Centre Toronto
10The National Cancer Institute of Canada Clinical Trials Group, Queen's University, Kingston, Ontario, Canada

Elizabeth A. Eisenhauer, M.D., FRCP(C) NCIC Clinical Trials Group, 82–84 Barrie Street Kingston, ON, Canada K7L 3N6

Background: The NCIC Clinical Trials Group has an ongoing interest in assessing investigational agents in minimally pretreated patients with malignant glioma. Topotecan is one of the first topoisomerase I inhibitors to enter clinical trials and has shown early evidence of activity in several solid tumors. We have conducted a phase II trial of topotecan in patients with malignant glioma.

Methods: Adults with malignant glioma and recurrent contrast enhancing measurable disease (>=2 x 2 cm) were eligible. Topotecan 1.5 mg/m2 i.v. was given daily x five days every three weeks. Response and toxic effects were assessed at the end of each cycle.

Results: Thirty-one patients were entered onto the study: fifteen had glioblastoma, 16 anaplastic astrocytoma, all had prior radiation, 15 prior chemotherapy, and all were assessable for response and toxicity. Two patients (6%) responded: one had a complete radiographic response, but died with neutropenic sepsis, and the second had a prolonged partial response (> 97 weeks). Twenty-one patients (68%) had stable disease for five to 86+ weeks (median 19) and eight (26%) had progressive disease after one cycle. Toxicity was primarily hematologic; 18 (58%) had grade 4 neutropenia (<0.5 x 109/1), usually brief, and three (10%) grade 4 thrombocytopenia (<25 x 109/1). Twelve of 109 cycles (11%) were given at reduced dose.

Conclusions: Topotecan in this dose and schedule has only modest activity in recurrent glioblastoma and anaplastic astrocytoma.

topotecan, phase II, malignant glioma


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