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Phase II trial of indicine N-oxide in relapsed pediatric solid tumors

โœ Scribed by James S. Miser; William A. Smithson; William Krivit; Carla Hughes; Dianne Davis; Mark Krailo; Denman Hammond


Publisher
Springer US
Year
1991
Tongue
English
Weight
280 KB
Volume
9
Category
Article
ISSN
0167-6997

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โœฆ Synopsis


We used indicine N-oxide to treat 46 children with malignant solid tumors: 17 with osteosarcoma, 12 with neuroblastoma, 13 with a brain tumor, and 4 with other miscellaneous tumors. The efficacy and toxicity of the drug was assessed at the dose of 2000 mg/m2/day for five consecutive days. None of the 39 patients evaluable for response achieved a complete or partial response. Hepatotoxicity was experienced by 13 patients: 11 patients developed asymptomatic elevations of transaminases, 1 patient developed hyperbilirubinemia, and 1 developed ascites. Indicine N-oxide appears to be ineffective in the treatment of osteosarcoma, neuroblastoma, and pediatric brain tumors at this dose and schedule. Because higher doses are associated with an unacceptably high incidence of severe, irreversible hepatotoxicity, we do not recommend further study of this agent in pediatric solid tumors.


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