Journal of Clinical Oncology, Vol 17, Issue 6
(June), 1999: 1815
© 1999 American Society for Clinical Oncology
Direct Translation of a Protracted Irinotecan Schedule From a Xenograft Model to a Phase I Trial in Children
Wayne L. Furman,
Clinton F. Stewart,
Catherine A. Poquette,
Charles B. Pratt,
Victor M. Santana,
William C. Zamboni,
Laura C. Bowman,
Margaret K. Ma,
Fredrick A. Hoffer,
William H. Meyer,
Alberto S. Pappo,
Andrew W. Walter,
Peter J. Houghton
From the Departments of Hematology-Oncology, Pharmaceutical Sciences, Biostatistics and Epidemiology, Diagnostic Imaging, and Molecular Pharmacology, St Jude Children's Research Hospital, Memphis; and the Department of Pediatrics, College of Medicine, University of Tennessee–Memphis, Memphis, TN.
Address reprint requests to Wayne L. Furman, MD, Department of Hematology-Oncology, St Jude Children's Research Hospital, 332 N Lauderdale, Memphis, TN 38105-2794; email wayne.furman{at}stjude.org
PURPOSE: In a preclinical model of neuroblastoma, administration of irinotecan daily 5 days per week for 2 consecutive weeks ([qd x 5] x 2) resulted in greater antitumor activity than did a single 5-day course with the same total dose. We evaluated this protracted schedule in children.
PATIENTS AND METHODS: Twenty-three children with refractory solid tumors were enrolled onto a phase I study. Cohorts received irinotecan by 1-hour intravenous infusion at 20, 24, or 29 mg/m2 (qd x 5) x 2 every 21 days.
RESULTS: The 23 children (median age, 14.1 years; median prior regimens, two) received 84 courses. Predominant diagnoses were neuroblastoma (n = 5), osteosarcoma (n = 5), and rhabdomyosarcoma (n = 4). The dose-limiting toxicity was grade 3/4 diarrhea and/or abdominal cramps in six of 12 patients treated at 24 mg/m2, despite aggressive use of loperamide. The maximum-tolerated dose (MTD) on this schedule was 20 mg/m2/d. Five patients had partial responses and 16 had disease stabilization. On day 1, the median systemic exposure to SN-38 (the active metabolite of irinotecan) at the MTD was 106 ng-h/mL (range, 41 to 421 ng-h/mL).
CONCLUSION: This protracted schedule is well tolerated in children. The absence of significant myelosuppression and encouraging clinical responses suggest compellingly that irinotecan be further evaluated in children using the (qd x 5) x 2 schedule, beginning at a dose of 20 mg/m2. These results imply that data obtained from xenograft models can be effectively integrated into the design of clinical trials.
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7(1):
32 - 37.
[Abstract]
[Full Text]
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P. J. Houghton, C. F. Stewart, P. J. Cheshire, L. B. Richmond, M. N. Kirstein, C. A. Poquette, M. Tan, H. S. Friedman, and T. P. Brent
Antitumor Activity of Temozolomide Combined with Irinotecan Is Partly Independent of O6-Methylguanine-DNA Methyltransferase and Mismatch Repair Phenotypes in Xenograft Models
Clin. Cancer Res.,
October 1, 2000;
6(10):
4110 - 4118.
[Abstract]
[Full Text]
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R. Khanna, C. L. Morton, M. K. Danks, and P. M. Potter
Proficient Metabolism of Irinotecan by a Human Intestinal Carboxylesterase
Cancer Res.,
September 1, 2000;
60(17):
4725 - 4728.
[Abstract]
[Full Text]
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C. L. Morton, M. Wierdl, L. Oliver, M. K. Ma, M. K. Danks, C. F. Stewart, J. L. Eiseman, and P. M. Potter
Activation of CPT-11 in Mice: Identification and Analysis of a Highly Effective Plasma Esterase
Cancer Res.,
August 1, 2000;
60(15):
4206 - 4210.
[Abstract]
[Full Text]
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M. K. Ma, W. C. Zamboni, K. M. Radomski, W. L. Furman, V. M. Santana, P. J. Houghton, S. K. Hanna, A. K. Smith, and C. F. Stewart
Pharmacokinetics of Irinotecan and Its Metabolites SN-38 and APC in Children with Recurrent Solid Tumors after Protracted Low-Dose Irinotecan
Clin. Cancer Res.,
March 1, 2000;
6(3):
813 - 819.
[Abstract]
[Full Text]
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