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Title of Journal: Invest New Drugs

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Abbravation: Investigational New Drugs

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Kluwer Academic Publishers

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DOI

10.1016/0021-9991(90)90136-o

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1573-0646

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Phase 1 trial of Anvirzel™ in patients with refrac

Authors: Tarek Mekhail Hanspreet Kaur Ram Ganapathi G Thomas Budd Paul Elson Ronald M Bukowski
Publish Date: 2006/04/05
Volume: 24, Issue: 5, Pages: 423-427
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Abstract

AnvirzelTM is an aqueous extract of the plant Nerium oleander which has been utilized to treat patients with advanced malignancies The current study reports a phase 1 trial to determine the maximum tolerated dose MTD and safety of AnvirzelTM in patients with advanced refractory solid tumors Patients were randomized to receive this agent by intramuscular injection at doses of 01 02 04 ml/m2/day with subsequent patients receiving 08 or 12 ml/m2/day sequentially Eighteen patients were enrolled and completed at least one treatment cycle of three weeks Most patients developed mild injection site pain 78 Other toxicities included fatigue nausea and dyspnea Traditional dose limiting toxicity was not seen but the MTD was defined by injection volume as 08 ml/m2/day No objective antitumor responses were seen Anvirzel™ can be safely administered at doses up to 12 ml/m2/day with the amount administered intramuscularly limited by volume The recommended phase II dose level is 08 ml/m2/day

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