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Phase I Trial of Multiple Large Doses of Murine Monoclonal Antibody CO17-1A. II. Pharmacokinetics and Immune Response1

Phase I Trial of Multiple Large Doses of Murine Monoclonal Antibody CO17-1A. II. Pharmacokinetics... Abstract Twenty-five patients with metastatic gastrointestinal adenocarcinoma received one to four infusions of large doses (400 mg) of murine monoclonal antibody CO17-1A (17-1A). The pharmacokinetics of 17-1A at the time of first, second, third, or fourth infusion were not statistically different; plasma half-lives were 15.0 ± 1.7 hours (n = 5), 15.1 ± 1.8 (n = 10), 25.3 ± 6.2 (n = 3), and 14.4 ± 1.8 (n = 5), respectively. Most patients had an antibody response to 17-1A, with peak levels occurring 15–22 days after infusion. The presence of serum antibody to 17-1A at the time of the second or third infusion did not significantly alter the pharmacokinetics of this large dose of antibody. Four of 25 patients failed to develop an antibody response, but this did not correlate with the amount of 17-1A administered. The administration of four doses of 400 mg over 1 week provided continuously circulating 17-1A for 10 days. [J Natl Cancer Inst 1988; 80: 937–942] This content is only available as a PDF. Author notes 2Supported by the Veterans Administration Medical Center and by Public Health Service grant CA-45232 from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services. 6We thank Barbara Irwin for aid in manuscript preparation. © Oxford University Press http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JNCI: Journal of the National Cancer Institute Oxford University Press

Phase I Trial of Multiple Large Doses of Murine Monoclonal Antibody CO17-1A. II. Pharmacokinetics and Immune Response1

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Publisher
Oxford University Press
Copyright
© Oxford University Press
ISSN
0027-8874
eISSN
1460-2105
DOI
10.1093/jnci/80.12.937
Publisher site
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Abstract

Abstract Twenty-five patients with metastatic gastrointestinal adenocarcinoma received one to four infusions of large doses (400 mg) of murine monoclonal antibody CO17-1A (17-1A). The pharmacokinetics of 17-1A at the time of first, second, third, or fourth infusion were not statistically different; plasma half-lives were 15.0 ± 1.7 hours (n = 5), 15.1 ± 1.8 (n = 10), 25.3 ± 6.2 (n = 3), and 14.4 ± 1.8 (n = 5), respectively. Most patients had an antibody response to 17-1A, with peak levels occurring 15–22 days after infusion. The presence of serum antibody to 17-1A at the time of the second or third infusion did not significantly alter the pharmacokinetics of this large dose of antibody. Four of 25 patients failed to develop an antibody response, but this did not correlate with the amount of 17-1A administered. The administration of four doses of 400 mg over 1 week provided continuously circulating 17-1A for 10 days. [J Natl Cancer Inst 1988; 80: 937–942] This content is only available as a PDF. Author notes 2Supported by the Veterans Administration Medical Center and by Public Health Service grant CA-45232 from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services. 6We thank Barbara Irwin for aid in manuscript preparation. © Oxford University Press

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JNCI: Journal of the National Cancer Institute – Oxford University Press

Published: Aug 17, 1988

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