The use of classical superantigens for treatment of
cancer has resulted in a low response rates and serious
toxicity in humans which is attributable, in part, to the presence of preformed
superantigen specific antibodies in the
plasma of treated patients. The present invention addresses this problem by providing a method for treating tumors comprising the administration of one or a plurality of egc (
enterotoxin gene cluster)
staphylococcal enterotoxins comprising
staphylococcal enterotoxins G, I, M, N, O. These superantigens in native unmodified form can be administered intrathecally, intratumorally, intravenously to humans with advanced
lung cancer while resolving pleural effusions and prolonging survival to 300% above control patients treated with
talc pleurodesis. Intratumoral egc superantigens induces a significant and sustained reduction of the
tumor size. In contrast to classic Sags, the egc superantigens induced minimal
toxicity, are rarely associated with the presence of preformed antibodies and are used as a plurality with a broad
T cell Vβ profile. Useful egc
superantigen compositions for parenteral administration native egc enterotoxins, homologues, fragments and fusion proteins of native egc enterotoxins capable of activating a
broad spectrum of T cells expressing
T cell receptor / α motifs.
T cell survival-enhancing cytokines IL-7, Il-15, Il-23 are used. together with parenteral egc SE therapy. Also disclosed is
combined therapy that includes parenteral, intratumoral or
intrathecal superantigen compositions in combination with (i) intratumoral low, non-toxic doses of one or more
chemotherapeutic drugs or (ii) systemic
chemotherapy at reduced and non-toxic doses of
chemotherapeutic drugs or (iii)
radiation therapy or (iv) anti-angiogenic and
tyrosine kinase inhibitors.