Phase I study of mitonafide in solid tumors
| Autor: | Vicente Guillem, Andres Poveda, Manuel Llombart, Erich Schlick, Ana Benavides, Cristóbal Gaspar, Miguel Martín, Virtudes Soriano, Miguel Muñoz, Amparo Ruiz, Ernesto Forner, Teresa Olmos, Carlos Fernández-Martos |
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| Rok vydání: | 1992 |
| Předmět: |
Adult
Male medicine.medical_treatment Antineoplastic Agents Imides Mitonafide Neoplasms medicine Humans Pharmacology (medical) Infusions Intravenous Aged Confusion Pharmacology Memory Disorders Chemotherapy Dose-Response Relationship Drug business.industry Drug administration Middle Aged Isoquinolines Phase i study Naphthalimides Dose–response relationship Oncology Anesthesia Toxicity Female medicine.symptom business Perfusion |
| Zdroj: | Investigational New Drugs. 10:177-181 |
| ISSN: | 1573-0646 0167-6997 |
| DOI: | 10.1007/bf00877243 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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