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Therapy of Patients with Malignant Melanoma Using a Monoclonal Antimelanoma Antibody-Ricin A Chain Immunotoxin¹

Department of Medicine, Children's Hospital [L. E. S., M. d. R., N. I. W., N. A. B., L. L. M., W. S. H.], San Francisco, California 94118, and XOMA Corporation [L. E. S., M. d. R., A. K., N. I. W., N. A. B., W. S. H., L. L. R., H. M. L., R. P. M., R. T. K., J. B. S., L. B. F., E. E. B., P. J. S.], Berkeley, California 94710

We conducted a trial of a murine monoclonal antimelanoma antibodyricin A chain immunotoxin (XOMAZYME-MEL) in 22 patients with metastatic malignant melanoma. The dose of immunotoxin administered ranged from 0.01 mg/kg daily for 5 days to 1 mg/kg daily for 4 days (total dose: 3.2 to 300 mg). Side effects observed in most patients were a transient fall in serum albumin with an associated fall in serum protein, weight gain, and fluid shifts resulting in edema. In addition, patients experienced mild to moderate malaise, fatigue, myalgia, decrease in appetite, and fevers. There was a transient decrease in voltage on electrocardiograms without clinical symptoms, change in serial echocardiograms or elevation of creatine phosphokinase MB isozyme levels. Symptoms consistent with mild allergic reactions were observed in three patients. The side effects were related to the dose of immunotoxin administered and were generally transient and reversible. Encouraging clinical results were observed, even after a single course of a low dose of immunotoxin. In addition, localization of antibody and A chain to sites of metastatic disease was demonstrated by immunoperoxidase staining of biopsy specimens. Additional studies are being conducted to continue the evaluation of safety and efficacy of immunotoxin therapy for malignancy.

¹ This project was supported by funds from XOMA Corporation. Presented in part at the First International Congress on Malignant Melanoma, Venice, Italy, 1985 (1).

² To whom requests for reprints should be addressed, at Xoma Corporation, 2910 Seventh Street, Berkeley, CA 94710.

Received 4/24/86. Revised 8/25/86. Revised 12/17/86. Accepted 12/19/86.

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