Initial clinical studies with copovithane

Gabriel N. Hortobagyi, Evan M. Hersh, Nicholas E.J. Papadopoulos, Debra Frye, Adan Rios, James M. Reuben, Carl Plager, Michael Rosenblum, Jorge Quesada

Research output: Contribution to journalArticlepeer-review

4 Scopus citations

Abstract

Copovithane is a new copolymer of low molecular weight and with a significant in vivo antitumor activity in preclinical trials. The mechanism of action is unknown. Ninety-one patients with various metastatic neoplasms beyond the curable stage were treated with Copovithane by weekly intravenous administration. Dose levels ranged from 1 to 33 g/m2/week. No dose-limiting toxicity was reached. Tolerance was excellent, with minor fatigue, occasional nausea, and intermittent proteinuria as the only significant side effects in less than 25% of patients. Two patients achieved a partial remission, and five patients reached minor responses during therapy. Antitumor effects were noted only in cutaneous and subcutaneous metastases. Extensive immunologic evaluation revealed some improvement in helper:suppressor T cell ratio, in vitro cytotoxicity tests, and lymphocyte blastogenic responses in patients treated at intermediate levels. The immunologic testing also suggested that the higher dose levels (22–33 g/m2 weekly) might adversely affect the immune response. The clinical relevance of these changes is uncertain. Phase II clinical trials are recommended utilizing weekly doses between 10 and 15 g/m2.

Original languageEnglish (US)
Pages (from-to)319-329
Number of pages11
JournalJournal of Biological Response Modifiers
Volume5
Issue number4
StatePublished - Aug 1986

Keywords

  • Antitumor effects
  • Copolymer
  • Copovithane
  • Tolerance
  • Toxicity

ASJC Scopus subject areas

  • Immunology
  • Pharmacology
  • Cancer Research

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