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A randomized, double‐blind, placebo‐controlled trial of transfer factor as adjuvant therapy for malignant melanoma
Author(s) -
Miller Langdon L.,
Spitler Lynn E.,
Allen Robert E.,
Minor David R.
Publication year - 1988
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/1097-0142(19880415)61:8<1543::aid-cncr2820610810>3.0.co;2-8
Subject(s) - medicine , melanoma , placebo , adjuvant therapy , randomized controlled trial , double blind , adjuvant , transfer factor , surgery , dermatology , oncology , cancer , pathology , cancer research , alternative medicine , immunology
One hundred and sixty‐eight evaluable patients participated in a randomized, double‐blind study of transfer factor (TF) versus placebo as surgical adjuvant therapy of Stage I and Stage II malignant melanoma. Eighty‐five patients received TF prepared from the leukocytes of healthy volunteer donors; eighty‐three participants received placebo. Therapy was initiated within 90 days of resection of all evident tumor and continued until 2 years of disease‐free survival or the occurrence of unresectable dissemination of melanoma. Known prognostic variables were similarly distributed in the treatment and control groups, documenting the randomization efficacy. Three endpoints were analyzed: disease‐free interval, time to Stage III metastasis, and survival. After a median follow‐up period of 24.75 months, there was a trend in favor of the placebo group with regard to all three endpoints and this was significant ( P ≦ 0.05) for time to Stage III metastasis. These findings indicate that TF is not effective as surgical adjuvant therapy of malignant melanoma.