The effect of thymosin on patients with disseminated malignancies. A phase I study.
A Phase I clinical trial of thymosin administered in doses of 10 to 250 mg/M2 intramuscularly for seven days was undertaken in ten patients with disseminated malignancies and evidence of immunoincompetence. Toxicity was minimal; one patient experienced a mild urticarial rash which cleared spontaneously, two patients developed low grade fever and one patient experienced pain at the injection site. There was no evidence of systemic toxicity or parenchymal organ dysfunction. Thymosin administration was associated with an increase in the E-rosette forming capacity of the patient's lymphocytes and the development of new skin test reactivity to recall antigens in some of these patients. One objective tumor response was noted. These findings are preliminary but are encouraging for further utilization of thymosin as an immunostimulant in cancer patients with immunoincompetence.
D000230:Adenocarcinoma / Q000188:drug therapy; D001943:Breast Neoplasms / Q000188:drug therapy; D003875:Drug Eruptions / Q000209:etiology; D004407:Dysgerminoma / Q000188:drug therapy; D006689:Hodgkin Disease / Q000188:drug therapy; D006801:Humans; D007104:Immune Adherence Reaction; D007111:Immunity, Cellular; D007890:Leiomyosarcoma / Q000188:drug therapy; D008175:Lung Neoplasms / Q000188:drug therapy; D008214:Lymphocytes / Q000276:immunology; D008545:Melanoma / Q000188:drug therapy; D009362:Neoplasm Metastasis; D009369:Neoplasms / Q000188:drug therapy*; D012882:Skin Tests; D013947:Thymosin / Q000009:adverse effects / Q000627:therapeutic use*; D013951:Thymus Hormones / Q000627:therapeutic use*
D013951:Thymus Hormones; D013947:Thymosin