Phase II trial of ixabepilone administered daily for five days in children and young adults with refractory solid tumors: A report from the children's oncology group

Shana Jacobs, Elizabeth Fox, Mark Krailo, Gwen Hartley, Fariba Navid, Leonard Wexler, Susan M. Blaney, Anne Goodwin, Wendy Goodspeed, Frank M. Balis, Peter C. Adamson, Brigitte C. Widemann

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Abstract

Purpose: Ixabepilone is a microtubule-stabilizing agent with activity in adult solid tumors and in pediatric tumor xenograft models that are resistant to paclitaxel. The maximum tolerated dose on the daily-for-5-days i.v. schedule was 6 mg/m2/dose in adults and 8 mg/m2/dose in children, and the primary dose-limiting toxicity (DLT) was neutropenia. This study aimed to determine the response rate to ixabepilone in six solid tumor strata in children and young adults. Experimental Design: We conducted a phase II trial of ixabepilone (8 mg/m2/dose for 5 days every 21 days) using a two-stage design in taxane-naïve children and young adults with treatment-refractory, measurable rhabdomyosarcoma, Ewing sarcoma family tumors, osteosarcoma, synovial sarcoma, or malignant peripheral nerve sheath tumor, neuroblastoma, and Wilms tumor. Results: Sixty-one eligible patients (36 male) were enrolled. Median (range) age was 13 years (range, 3-36). Fifty-nine patients were fully evaluable for toxicity and response. DLTs, most commonly myelosuppression, occurred in 11 patients (15% incidence in 3-18 years old and 33% in 19-36 years old; P = 0.2) during cycle 1. The median (range) number of cycles was 2 (range, 1-38). No partial or complete responses (response evaluation criteria in solid tumors) were observed. Seven patients received ≥3 cycles, and two had prolonged stable disease (Wilms' tumor, 38 cycles; synovial sarcoma, 8 cycles). Conclusions: Ixabepilone at 8 mg/m2/dose daily for 5 days was tolerable in children and adolescents, but did not show evidence of clinical activity in the childhood solid tumors studied.

Original languageEnglish (US)
Pages (from-to)750-754
Number of pages5
JournalClinical Cancer Research
Volume16
Issue number2
DOIs
Publication statusPublished - Jan 15 2010
Externally publishedYes

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ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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