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

S. Blaney, S. L. Berg, C. Pratt, Steven D Weitman, J. Sullivan, L. Luchtman-Jones, M. Bernstein

Research output: Contribution to journalArticle

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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/m2 to 65 mg/m2. An 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/m2, and the MTD in the less-heavily pretreated patients was 50 mg/m2. Non-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/m2 in heavily treated and 50 mg/m2 in less-heavily children with solid tumors.

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

Fingerprint

irinotecan
Pediatrics
Maximum Tolerated Dose
Neuroblastoma
Diarrhea
Rhabdoid Tumor
Pelvic Bones
Pinealoma
Hepatoblastoma
Ondansetron
Central Nervous System Neoplasms
Neoplasms
Premedication

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Blaney, S., Berg, S. L., Pratt, C., Weitman, S. D., Sullivan, J., Luchtman-Jones, L., & Bernstein, M. (2001). A Phase I study of irinotecan in pediatric patients: A pediatric oncology group study. Clinical Cancer Research, 7(1), 32-37.

A Phase I study of irinotecan in pediatric patients : A pediatric oncology group study. / Blaney, S.; Berg, S. L.; Pratt, C.; Weitman, Steven D; Sullivan, J.; Luchtman-Jones, L.; Bernstein, M.

In: Clinical Cancer Research, Vol. 7, No. 1, 2001, p. 32-37.

Research output: Contribution to journalArticle

Blaney, S, Berg, SL, Pratt, C, Weitman, SD, Sullivan, J, Luchtman-Jones, L & Bernstein, M 2001, 'A Phase I study of irinotecan in pediatric patients: A pediatric oncology group study', Clinical Cancer Research, vol. 7, no. 1, pp. 32-37.
Blaney S, Berg SL, Pratt C, Weitman SD, Sullivan J, Luchtman-Jones L et al. A Phase I study of irinotecan in pediatric patients: A pediatric oncology group study. Clinical Cancer Research. 2001;7(1):32-37.
Blaney, S. ; Berg, S. L. ; Pratt, C. ; Weitman, Steven D ; Sullivan, J. ; Luchtman-Jones, L. ; Bernstein, M. / A Phase I study of irinotecan in pediatric patients : A pediatric oncology group study. In: Clinical Cancer Research. 2001 ; Vol. 7, No. 1. pp. 32-37.
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