Literature DB >> 8777179

Phase II study of topotecan in patients with recurrent malignant glioma. National Clinical Institute of Canada Clinical Trials Group.

D Macdonald1, G Cairncross, D Stewart, P Forsyth, C Sawka, N Wainman, E Eisenhauer.   

Abstract

BACKGROUND: The NCIC Clinical Trial 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 (> or = 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 10(9)/1), usually brief, and three (10%) grade 4 thrombocytopenia (< 25 x 10(9)/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.

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Year:  1996        PMID: 8777179     DOI: 10.1093/oxfordjournals.annonc.a010550

Source DB:  PubMed          Journal:  Ann Oncol        ISSN: 0923-7534            Impact factor:   32.976


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