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A Randomized Trial of Levamisole versus Placebo as Adjuvant Therapy in Malignant Melanoma

List of authors.
  • Lynn E. Spitler, M.D.,
  • and Richard Sagebiel, M.D.

Abstract

We conducted a randomized double-blind trial of levamisole versus placebo as adjuvant therapy for surgical treatment of melanoma. Of 203 patients entered into the study, 104 received levamisole and 99 placebo. The distribution of prognostic variables was similar in both groups, indicating the efficacy of the randomization and the absence of bias. Three end points were analyzed: disease-free interval, time to appearance of visceral metastasis, and survival. There was no statistically significant difference between the groups regarding any of these end points. In patients with Stage I disease, there was a trend in favor of levamisole regarding time to first visceral recurrence and survival (P = 0.07). We conclude that levamisole has no benefit, as compared with placebo, as adjuvant therapy for malignant melanoma. (N Engl J Med. 1980; 303: 1143–7.)

Funding and Disclosures

Supported by a gift from Janssen Pharmaceutica and a grant (CA-13671) from the U.S. Public Health Service.

Presented at the First and Second International Congresses on Immunotherapy, National Cancer Institute, Bethesda, Md., 1976 and 1980.

We are indebted to Drs. William Brown and Alvaro Munoz for assistance in the statistical analysis of the data, to the members of the Melanoma Consulting Board, Drs. Robert Allen, Scott Blois, Richard Dakin, Thomas Drake, Cleo Dymott, William Epstein, and David Minor, for their assistance in the care of these patients, to the Fellows who also participated in the care of these patients, Drs. Randolph Chase, James Clarkson, Peter De Green, David Gandara, Richard Glogau, Raymond Gonzales, Michael Gromet, David Levinson, Fred Littooy, Thomas Malm, William Popovic, John Redmond, William Thompson, and Peter Wong, to the physicians who referred patients for participation in the study, took responsibility for primary care of the patients, and encouraged their continuing participation, and to Christine Suquet and Nenita Arias for technical assistance.

Author Affiliations

From the Paul M. Aggelar Memorial Laboratory, Children's Hospital and the departments of Medicine and Pathology, the University of California Medical Center, San Francisco. Address reprint requests to Dr. Spitler at the Children's Hospital, 3700 California St., San Francisco, CA 94119.

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