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Phase I trial of pentosan polysulfate

  • Phase I Studies
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Summary

Pentosan polysulfate is a semisynthetic pentasaccharide heparinoid derived from beechwood shavings. A total of nineteen patients with various adult solid tumors were treated with three dose levels (15, 22.5, and 30 mg/m2/dose) of subcutaneous pentosan polysulfate every 6 hours. The dose limiting toxicities were thrombocytopenia and elevated transaminases at the dose of 30 mg/m2 every 6 hours. The recommended starting dose for phase II trials is 22.5 mg/m2 given every 6 hours. There was an increase in anticoagulant activity as measured by activated partial thromboplastin time (aPTT) at the dose of 22.5 mg/m2 every 6 hours in most patients. There were no objective responses and three patients had stable disease lasting 16, 19 and 76 weeks.

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Authors and Affiliations

  1. Clinical Oncology Programs, National Cancer Institute, Medical Oncology Branch, 20007, Washington, D.C., USA

    Bernard Parker

  2. Department of Pharmacology, Lombardi Cancer Research Center, Georgetown University, 20007, Washington, D.C., USA

    Anton Wellstein

  3. Department of Medicine, Lombardi Cancer Research Center, Georgetown University, 20007, Washington, D.C., USA

    Marc E. Lippman & Caryn Steakley

  4. Division of Oncology and Pulmonary Drug Products, Food and Drug Administration, USA

    Robert DeLap

  5. 5230 Baltimore Ave., 20816, Bethesda, MD, USA

    Sandra M. Swain

Authors
  1. Sandra M. Swain
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  2. Bernard Parker
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  3. Anton Wellstein
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  4. Marc E. Lippman
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  5. Caryn Steakley
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  6. Robert DeLap
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Swain, S.M., Parker, B., Wellstein, A. et al. Phase I trial of pentosan polysulfate. Invest New Drugs 13, 55–62 (1995). https://doi.org/10.1007/BF02614221

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  • DOI: https://doi.org/10.1007/BF02614221

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