A North Central Cancer Treatment Group phase II trial of topotecan in relapsed gliomas

Patrick A. Burch, Albert M. Bernath, Terrence L. Cascino, Bernd W. Scheithauer, Paul Novotny, Suresh Nair, Jan C. Buckner, Delano M. Pfeifle, John W. Kugler, Loren K. Tschetter

Research output: Contribution to journalArticlepeer-review

20 Scopus citations


Current systemic treatment options for patients with relapsed gliomas are limited. The topoisomerase I inhibitor topotecan has demonstrated broad antitumor activity in both preclinical studies as well as a number of phase I and II trials in humans. Studies in primates have shown good cerebrospinal fluid levels of topotecan following systemic administration. We therefore performed this phase II trial in patients who developed evidence of progressive glioma after definitive radiation therapy. Patients were treated with 1.5 mg/m2 intravenously daily for 5 consecutive days repeated every three weeks. For patients who had received prior nitrosourea-containing chemotherapy, the starting dose was 1.25 mg/m2. Thirty-three patients were entered on this study. All patients were eligible and evaluable for both response and toxicity. Seven patients experienced grade 4 leukopenia with 2 of these patients dying of infection-related complications. Six of these seven patients were not taking anticonvulsants during treatment. Nine patients developed grade 3-4 thrombocytopenia, seven of whom were not taking anticonvulsants. Nonhematologic side effects were infrequent and manageable. One patient experienced a partial response to this treatment for an overall response rate of 3% (95% binomial confidence interval 0.3%-20.4%). The median time to progression was 14.9 weeks and median survival 19.9 weeks. Topotecan at this dose and schedule showed no substantial activity in relapsed gliomas.

Original languageEnglish (US)
Pages (from-to)275-280
Number of pages6
JournalInvestigational New Drugs
Issue number3
StatePublished - 2000


  • Antitumor activity
  • Gliomas
  • Phase II trial
  • Topotecan
  • Toxicity

ASJC Scopus subject areas

  • Oncology
  • Pharmacology
  • Pharmacology (medical)


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