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Summary: The antitumor activity of recombinant human tumor necrosis factor (rhTNF) against methylcholanthrene A-induced sarcoma (Meth A sarcoma) and human tumors in vivo was studied. On systemic administration of rhTNF to Meth A sarcoma-bearing mice, tumor regression was achieved with a large dose or with repeated administration of a small dose. Strong antitumor activity could be achieved in the Meth A sarcoma model by administration of a small dose of rhTNF in combination with moderate temperature hyperthermia (p < 0.005). rhTNF (1,000 U/mouse) combined with moderate hyperthermia (40[degrees]C for 40 min) within 2 h after the TNF administration effected 100% complete regression. In contrast, the rhTNF or moderate hyperthermia alone revealed 0% complete regression. The antitumor activity of rhTNF was decreased in combination with cyclophosphamide (0.6 or 1.2 mg/mouse) (p < 0.005). However, in combination with mitomycin C (30 or 120 [mu]g/mouse), the antitumor activity of rhTNF was enhanced (p < 0.005). In combination with immunotherapy (lentinan or OK 432), the antitumor activity was mostly enhanced. Repeated rhTNF administration also displayed antitumor activity in heterotransplanted human tumors (p < 0.005). The antitumor activity of TNF was enhanced by repeated administration of even small dosages, in combination with hyperthermia, or in combination with immunotherapy.

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