A randomized, double-blind, placebo-controlled trial of transfer factor as adjuvant therapy for malignant melanoma

Abstract

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.

Vaccine Therapy of Melanoma: An Update

“…Levamisole ultimately was utilized, along with 5-fluorouracil, for the adjuvant treatment of carcinoma of the colon. Transfer factor, an extract of disrupted leukocytes thought to transfer delayedtype hypersensitivity and act as a non-specific immunostimulant, was also tested in two small randomized, controlled trials in melanoma without evidence of clinical efficacy [43,44]. Studies with isoprinosine, a mixture of inosine, adedoben and dimepranol with putative immunostimulatory properties, and the thymic factor thymostimulin likewise showed no evidence these immunostimulants could prevent melanoma recurrence [45,46].…”

Current state of treatment for primary cutaneous melanoma

“…To this end, transfer factor used in preliminary investigations of its role in the treatment of melanoma was obtained from donors whose lymphocytes demonstrated reactivity to melanoma antigens (typically melanoma patients who had undergone disease regression or surgical cure, and family members and close contacts of the study subjects) [84,85]. Based on encouraging results obtained in these early studies in patients with metastatic disease [84,85], two small clinical trials were performed to test the efficacy of transfer factor on melanoma in the adjuvant setting [86,87]. The material used for these studies was obtained from normal healthy donors, based on the knowledge that transfer factor exerts both specific and nonspecific effects on cellular immunity.…”

Melanoma: Adjuvant therapy and other treatment options

“…Transfer factor used in preliminary investigations of its role in the treatment of melanoma was obtained from donors whose lymphocytes demonstrated reactivity to melanoma antigens (typically patients with melanoma who had undergone disease regression or surgical cure, and family members and close contacts of the study subjects) [26,27]. • Based on encouraging results obtained in these early studies in patients with metastatic disease [26,27], two small clinical trials were performed to test the efficacy of transfer factor on melanoma in the adjuvant setting [28,29]. The material used for these studies was obtained from normal healthy donors, based on the knowledge that transfer factor exerts specific and nonspecific effects on cellular immunity.…”