Phase 2 study of weekly irinotecan in adults with recurrent malignant glioma: Final report of NABTT 97-11

Academic Article


  • The primary objective of this study was to determine the proportion of patients exhibiting a radiographic response in a cohort of patients with recurrent malignant glioma who were treated with irinotecan. Secondary objectives were to determine progression-free survival, overall survival, and toxicity. The trial was terminated after the first 18 patients were enrolled in this multicenter, 2-stage, phase 2 study. Twelve patients received concurrent enzyme-inducing antiepileptic drugs, and 6 did not. Each cycle consisted of a 90-min i.v. infusion of irinotecan every week for 4 consecutive weeks, followed by 2 weeks off. One patient had a complete response, 5 patients had stable disease, 5 patients had radiographic progression, 6 patients were removed from the study because of toxicity, and 1 patient refused further therapy and was removed from the study. The response rate in this study was 6% (1/18), and 28% (5/18) of these patients progressed while receiving irinotecan. Dose-limiting toxicities consisted of diarrhea in 5 patients, neutropenia in 1 patient, infection in 1 patient, and respiratory failure in 1 patient. Irinotecan had minimal efficacy in this cohort of 18 patients with recurrent malignant glioma. Toxicity was significant but similar to that reported in other patient populations.
  • Published In

  • Neuro-Oncology  Journal
  • Digital Object Identifier (doi)

    Author List

  • Batchelor TT; Gilbert MR; Supko JG; Carson KA; Nabors LB; Grossman SA; Lesser GJ; Mikkelsen T; Phuphanich S
  • Start Page

  • 21
  • End Page

  • 27
  • Volume

  • 6
  • Issue

  • 1