[HTML][HTML] Phase I Study of 6-Diazo-5-oxo-L-norleucine (DON) 1, 2, 3

RB Sklaroff, ES Casper, GB Magill… - Cancer treatment …, 1980 - books.google.com
RB Sklaroff, ES Casper, GB Magill, CW Young
Cancer treatment reports, 1980books.google.com
We conducted a phase I study of 6-diazo-5-oxo-L-norleucine given iv on a twice weekly
schedule. Twenty-six evaluable patients received 31 courses of the drug. Doses ranged
from 100 to 500 mg/m². Nausea with vomiting was the dose-limiting toxic effect, transient
thrombocytopenia was seen frequently, and mucositis occurred in 39% of the patients. No
definite therapeutic responses were observed in 18 patients with measurable lesions. The
recommended dose for phase II studies is 200-300 mg/m² iv twice weekly.
Summary
We conducted a phase I study of 6-diazo-5-oxo-L-norleucine given iv on a twice weekly schedule. Twenty-six evaluable patients received 31 courses of the drug. Doses ranged from 100 to 500 mg/m². Nausea with vomiting was the dose-limiting toxic effect, transient thrombocytopenia was seen frequently, and mucositis occurred in 39% of the patients. No definite therapeutic responses were observed in 18 patients with measurable lesions. The recommended dose for phase II studies is 200-300 mg/m² iv twice weekly.
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