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Phase 1 trial of Anvirzel™ in patients with refractory solid tumors

  • Phase I Studies
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Summary

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 0.1, 0.2, 0.4 ml/m2/day with subsequent patients receiving 0.8 or 1.2 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 0.8 ml/m2/day. No objective anti-tumor responses were seen. Anvirzel™ can be safely administered at doses up to 1.2 ml/m2/day, with the amount administered intramuscularly limited by volume. The recommended phase II dose level is 0.8 ml/m2/day.

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Authors and Affiliations

  1. Taussig Cancer Center, Cleveland Clinic Foundation, Cleveland, Case Comprehensive Cancer Center, 9500 Euclid Ave., Cleveland, OH, 44195

    Tarek Mekhail, Ram Ganapathi, G. Thomas Budd, Paul Elson & Ronald M. Bukowski

  2. Ireland Cancer Center, University Hospitals, Case Comprehensive Cancer Center, Ireland

    Hanspreet Kaur

Authors
  1. Tarek Mekhail
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  2. Hanspreet Kaur
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  3. Ram Ganapathi
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  4. G. Thomas Budd
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  5. Paul Elson
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  6. Ronald M. Bukowski
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Correspondence to Tarek Mekhail.

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Mekhail, T., Kaur, H., Ganapathi, R. et al. Phase 1 trial of Anvirzel™ in patients with refractory solid tumors. Invest New Drugs 24, 423–427 (2006). https://doi.org/10.1007/s10637-006-7772-x

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  • DOI: https://doi.org/10.1007/s10637-006-7772-x

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