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Phase 2 study of weekly irinotecan in adults with recurrent malignant glioma:
Final report of NABTT 97-11
Tracy T. Batchelor, Mark R. Gilbert, Jeffrey G. Supko, Kathryn A. Carson,
Louis B. Nabors, Stuart A. Grossman, Glenn J. Lesser, Tom Mikkelsen, and Surasak
Phuphanich for the NABTT CNS Consortium
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.
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.
© 2003 Duke University Press
Source: http://juno.ingentaselect.com/cgi-bin/linker?ini=dup_no&reqidx=/cw/dup/15228517/v6n1/s4/p21
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