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We performed a phase I and pharmacokinetic study of thalidomide with carboplatin in children with refractory solid tumors. <\/jats:p><\/jats:sec><jats:sec><jats:title>Patients and Methods<\/jats:title><jats:p> Carboplatin was administered as a single intravenous dose once every 21 days at a target area under the concentration-time curve of 6 mg\/mL\u00b7min. Thalidomide was administered daily by mouth. The initial dose level was 100 mg\/m<jats:sup>2<\/jats:sup>\/d with intrapatient dose escalation to a maximum dose of 300 mg\/m<jats:sup>2<\/jats:sup>\/d. The next cohort of patients started at a dose of 300 mg\/m<jats:sup>2<\/jats:sup>\/d, with intrapatient dose escalation to a maximum dose of 500 mg\/m<jats:sup>2<\/jats:sup>\/d. Standard response and adverse event criteria were used. Serial blood samples for thalidomide pharmacokinetics studies were obtained after the first dose. <\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p> Twenty-two patients received 56 cycles of therapy. The maximum tolerated thalidomide dose was 400 mg\/m<jats:sup>2<\/jats:sup>\/d. The dose-limiting toxicity was somnolence. There were no objective responses. Thalidomide's apparent clearance was 55 \u00b1 16 mL\/min\/m<jats:sup>2<\/jats:sup> and the terminal half-life was 5.9 \u00b1 2.8 hours. There was no evidence of dose-dependent pharmacokinetics in the narrow range studied. <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p> Thalidomide at a dose of 400 mg\/m<jats:sup>2<\/jats:sup>\/d can be safely administered to children with solid tumors in combination with carboplatin. Somnolence is the major toxicity. In addition, we have characterized the pharmacokinetic behavior of thalidomide in children. 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