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

Brain Tumor Center (T.T.B.) and Division of Hematology and Medical Oncology (J.G.S.), Massachusetts General Hospital, Boston, MA 02114; Department of Neuro-Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, TX 77030 (M.R.G.); The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD 21231 (K.A.C., S.A.G.); Department of Neurology, University of Alabama, Birmingham, AL 35294 (L.B.N.); Department of Hematology and Oncology, Wake Forest University Baptist Medical Center, Winston-Salem, NC 27157 (G.J.L.); Henry Ford Hospital, Detroit, MI 48202 (T.M.); Division of Neuro-Oncology, H. Lee Moffitt Cancer Center, Tampa, FL 33612 (S.P.); USA

² Address correspondence to Stuart A. Grossman, The Sidney Kimmel Comprehensive Cancer Center, G87 Bunting-Blaustein Research Building, 1650 Orleans St., Baltimore, MD 21231-1000, USA (grossman{at}jhmi.edu).

Abstract

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.

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