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Phase I study of mitonafide in solid tumors.

M Llombart¹, A Poveda, E Forner

¹Instituto Valenciano de Oncologia (IVO), Spain.

Investigational New Drugs

|August 1, 1992

Summary

Mitonafide, a novel 3-nitronaphthalimide, showed dose-limiting central nervous system toxicity, including irreversible memory loss, in a phase I trial. Further studies with short intravenous infusions are not recommended due to this toxicity.

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Area of Science:

Oncology
Pharmacology
Toxicology

Background:

Mitonafide is a novel 3-nitronaphthalimide derivative.
It exhibits DNA intercalative properties, suggesting potential anticancer activity.

Purpose of the Study:

To evaluate the safety and tolerability of mitonafide in a phase I clinical trial.
To determine the dose-limiting toxicity of mitonafide administered via short intravenous infusions.

Main Methods:

A phase I dose-escalation study was conducted.
Thirty patients received mitonafide daily for 5 days every 21 days via short (1-hour) intravenous infusions.
Doses ranged from 15.4 mg/m²/day to 138.6 mg/m²/day.

Main Results:

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The study was halted due to central nervous system (CNS) toxicity in 5 patients at doses above 118 mg/m²/day.

All affected patients experienced irreversible memory loss.

Three patients progressed to disorientation and confusion, with one developing dementia.

Conclusions:

Short intravenous infusions of mitonafide are associated with dose-limiting CNS toxicity, specifically irreversible memory loss.
This administration schedule is not recommended for future studies.
Alternative administration schedules are being investigated in ongoing phase I trials.