Phase I study of mitonafide in solid tumors.
Invest New Drugs
; 10(3): 177-81, 1992 Aug.
Article
en En
| MEDLINE
| ID: mdl-1428727
ABSTRACT
Mitonafide was the first synthetized compound of a new series of 3-nitronaphthalimides with intercalative properties. A phase I study with a conventional escalation scheme was developed. The schedule of drug administration was a daily x 5 days by short (1 h) intravenous (i.v.) infusion, every 21 days. Thirty evaluable patients were treated at doses from 15.4 mg/m2/d x 5 days to 138.6 mg/m2/d x 5 days. The study was interrupted due to appearance of central nervous system toxicity in 5 patients treated at doses above 118 mg/m2 x 5 days. This toxicity consisted firstly of loss of memory in all patients. It was irreversible and progressed in 3 patients to disorientation and confusion, leading to dementia in one of them. This was considered to be dose-limiting toxicity, and since it appeared to be related to the administration schedule, no further studies with short i.v. infusions of mitonafide are recommended. A phase I study utilizing a more desirable administration schedule over longer periods of time is ongoing in other centers.
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Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Imidas
/
Isoquinolinas
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Neoplasias
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Antineoplásicos
Límite:
Adult
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Aged
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Female
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Humans
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Male
/
Middle aged
Idioma:
En
Revista:
Invest New Drugs
Año:
1992
Tipo del documento:
Article
País de afiliación:
España