Purpose: The prognosis for patients with metastasized malignant melanoma is very poor, and an effective therapy is warranted. Previous studies of adoptive T cell transfer have been encouraging, but have sometimes exhibited severe side effects. We sought to refine earlier applied protocols by using low-dose instead of high-dose IL-2 as a supporting cytokine.
Experimental design: We evaluated the adoptive transfer of autologous T cells in combination with low-dose s.c. IL-2 in 28 melanoma patients with advanced disease. The patients had progressed on standard treatments. They were pretreated with high-dose chemotherapy for obtaining lymphodepletion to augment the anti-tumor function of the transferred T cells.
Results: The objective response rate was18 %. One patient obtained a long-lasting complete remission and four patients a partial response. Tumor regression was demonstrated in six further patients (21 %) without reaching the RECIST criteria for a partial response.
Conclusions: This is the first study in cancer patients with autologous T cell transfer combined with low-dose s.c. IL-2. The results are promising but modifications of the protocol are needed to increase the response rate.