A Phase I study of irinotecan in pediatric patients: A pediatric oncology group study

Susan Blaney, Stacey L. Berg, Charles Pratt, Steve Weitman, Jim Sullivan, Lori Luchtman-Jones, Mark Bernstein

Research output: Contribution to journalArticlepeer-review

91 Scopus citations

Abstract

A Phase I trial of irinotecan was performed to determine the maximum tolerated dose (MTD), the dose-limiting toxicities (DLTs), and the incidence and severity of other toxicities in children with refractory solid tumors. Thirty-five children received 146 courses of irinotecan administered as a 60-min i.v. infusion, daily for 5 days, every 21 days, after premedication with dexamethasone and ondansetron. Doses ranged from 30 mg/m2to 65 mg/m2An MTD was defined in heavily pretreated and less-heavily pretreated (i.e., two prior chemotherapy regimens, no prior bone marrow transplantation, and no radiation to the spine, skull, ribs, or pelvic bones) patients. Myelosuppression was the primary DLT in heavily pretreated patients, and diarrhea was the DLT in less-heavily pretreated patients. The MTD in the heavily pretreated patient group was 39 mg/m2and the MTD in the less-heavily pretreated patients was 50 mg/m2Non-doselimiting diarrhea that was well controlled and of brief duration was observed in approximately 75% of patients. A partial response was observed in one patient with neuroblastoma, and in one patient with hepatocellular carcinoma. Stable disease (4-20 cycles) was observed in seven patients with a variety of malignancies including neuroblastoma, pineoblastoma, glioblastoma, brainstem glioma, osteosarcoma, hepatoblastoma, and a central nervous system rhabdoid tumor. In conclusion, the recommended Phase II dose of irinotecan administered as a 60-min i.v. infusion daily for 5 days, every 21 days, is 39 mg/m2in heavily treated and 50 mg/m2in less-heavily children with solid tumors.

Original languageEnglish (US)
Pages (from-to)32-37
Number of pages6
JournalClinical Cancer Research
Volume7
Issue number1
StatePublished - Jan 2001
Externally publishedYes

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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