Phase I trial of indicine-N-oxide in children with leukemia and solid tumors: a Pediatric Oncology Group study.

Abstract

A phase I trial of indicine-N-oxide was carried out in 12 children with solid tumors and in 16 with leukemia. Doses of 5, 6, and 7.5 g/m2 were given parenterally as a 15-min infusion every 3 weeks. The maximum tolerated dose in patients with solid tumors was 7.5 g/m2 and the dose-limiting toxicity was myelosuppression. In leukemia, the maximum tolerated dose was 6.0 g/m2 and hepatotoxicity was dose-limiting. Half of the children with leukemia showed elevations in transaminase levels and one child died of massive hepatic necrosis. This hepatotoxicity limits the use of indicine-N-oxide in children with leukemia. Antineoplastic activity was limited to a transient reduction in the numbers of circulating leukemic cells.

• Authors: V M Whitehead, M L Bernstein, R Vega, T Vats, P Dyment, T J Vietti, J Krischer
• Journal: Cancer chemotherapy and pharmacology (Cancer Chemother Pharmacol) Vol. 26 Issue 5 Pg. 377-9 ( 1990) ISSN: 0344-5704 [Print] Germany
• PMID: 2208580 (Publication Type: Journal Article, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Antineoplastic Agents, Phytogenic
• Pyrrolizidine Alkaloids
• indicine-N-oxide

Topics

• Adolescent
• Antineoplastic Agents, Phytogenic (administration & dosage, adverse effects, therapeutic use)
• Child
• Child, Preschool
• Drug Administration Schedule
• Drug Evaluation
• Humans
• Infusions, Intravenous
• Leukemia (drug therapy)
• Liver (drug effects, enzymology)
• Male
• Neoplasms (drug therapy)
• Pyrrolizidine Alkaloids (administration & dosage, adverse effects, therapeutic use)
• Thrombocytopenia (chemically induced)