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JNCI Journal of the National Cancer Institute 1988 80(16):1325-1328; doi:10.1093/jnci/80.16.1325
© 1988 by Oxford University Press
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Journal of the National Cancer Institute, Vol. 80, No. 16, 1325-1328, October 19, 1988
© 1988 Oxford University Press

Phase I Study of Weekly 24-hour Infusions of Recombinant Human Interleukin-22

Jon M. Richards*, Ellen Barker, Jill Latta, Kathleen Ramming, Nicholas J. Vogelzang3,4

2Supported in part by Cetus Corporation and Public Health Service grant DK-13412 from the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services.
3Joint Section of Hematology/Oncology, Department of Medicine, University of Chicago Chicago, IL

*Correspondence to: Dr. Jon M. Richards, Joint Section of Hematology/Oncology, Department of Medicine, University of Chicago, 5841 S. Maryland Ave., Box 420, Chicago, IL 60637.

Sixteen patients with metastatic melanoma or metastatic renal cell carcinoma were treated with six weekly 24-hour infusions of recombinant interleukin-2. At least three patients were treated at each dose, beginning at 3.0 mU/m2 for 24 hours each week for 6 weeks. Subsequent patients were treated at 4.5, 6.0, 8.0, and 10.0 mU/m2 for 24 hours. The incidence of diarrhea, rigors, rash, edema, and symptomatic hypotension was positively correlated with dose level. Symptomatic hypotension was dose limiting at the 10-mU/m2 level. Fever, nau-sea, and vomiting were seen at each dose level and could not be correlated with dose level. Lymphopenia and eosinophilia were observed at the completion of each 24-hour infusion, and an increase in peripheral blood absolute lymphocytes and eosinophils was observed over the 6-week treatment period. No thrombocytopenia was observed. No change in delayed-type hy-persensitivity [type IV) as determined by skin testing could be demostrated at any dose level. Natural killer cell cy-totoxicity of peripheral blood lymphocytes increased over the treatment period, but the increase was unrelated to dose level in the range studied. One minor response was documented in a patient with renal cell carcinoma.



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