Initial clinical studies with copovithane.

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.

• Authors: G N Hortobagyi, E M Hersh, N E Papadopoulos, D Frye, A Rios, J M Reuben, C Plager, M Rosenblum, J Quesada
• Journal: Journal of biological response modifiers (J Biol Response Mod) Vol. 5 Issue 4 Pg. 319-29 (Aug 1986) ISSN: 0732-6580 [Print] United States
• PMID: 2942646 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Antineoplastic Agents
• Carbamates
• copovithane
• Povidone

Topics

• Adult
• Aged
• Antineoplastic Agents (therapeutic use)
• Carbamates (administration & dosage, adverse effects, therapeutic use)
• Cytotoxicity, Immunologic (drug effects)
• Drug Evaluation
• Drug Tolerance
• Female
• Humans
• Immunity, Cellular (drug effects)
• In Vitro Techniques
• Lymphocyte Activation (drug effects)
• Male
• Melanoma (drug therapy)
• Middle Aged
• Neoplasms (drug therapy, immunology)
• Povidone (administration & dosage, adverse effects, therapeutic use)
• T-Lymphocytes, Helper-Inducer (drug effects)
• T-Lymphocytes, Regulatory (drug effects)