Treatment of metastatic renal cell carcinoma with activated autologous macrophages and granulocyte--macrophage colony-stimulating factor.

Fifteen patients with progressive metastatic renal cell carcinoma were treated with granulocyte-macrophage colony-stimulating factor and intravenous infusions of activated autologous macrophages (AAMs). The latter were prepared from leukapheresis-separated mononuclear cells cultured in the presence of granulocyte-macrophage colony-stimulating factor, exposed to gamma interferon, and submitted to elutriation to separate AAMs. Three intravenous injections of AAMs were performed within a 2-week interval. This treatment cycle was repeated once or twice, in cases of tumor response or stabilization. Ninety-seven preparations containing a mean 3 x 10 9 AAMs were administered and usually well tolerated. One partial response, eight stabilizations and six progressions were observed. The median time to progression and median overall survival time after inclusion were 7 and 9 months, respectively. The cells injected did not accumulate substantially in tumor lesions, as shown by scintigraphic imaging of indium-111-labeled AAMs. Thus, combined granulocyte-macrophage colony-stimulating factor and AAM treatment was well tolerated and resulted in transitory stabilization (n = 8) or partial regression (n = 1) in 9 of 15 patients.