A randomized, double-blind, placebo-controlled trial of transfer factor as adjuvant therapy for malignant melanoma.
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 less than or equal to 0.05) for time to Stage III metastasis. These findings indicate that TF is not effective as surgical adjuvant therapy of malignant melanoma.
Miller
L L
LL
Paul M. Aggelar Memorial Laboratory, Children's Hospital of San Francisco, California.
Spitler
L E
LE
Allen
R E
RE
Minor
D R
DR
D002986:Clinical Trials as Topic; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D006801:Humans; D008545:Melanoma / Q000601:surgery / Q000628:therapy*; D011897:Random Allocation; D014165:Transfer Factor / Q000627:therapeutic use*
D014165:Transfer Factor