The cytotoxic ability of T-cells against tumor cells may be increased by interleukin (IL)-2. The infiltration of tumors by these cytotoxic T-cells may be enhanced by low-dose cyclophosphamide, which may also serve to deplete regulatory T-cells. Famotidine may increase IL-2 internalization by the IL-2 receptor on T-lymphocytes. We have treated 14 patients with either metastatic melanoma or kidney cancer, using CY 350 mg/M(2) intravenously (i.v.) over 1 hour followed by a continuous infusion IL-2 9 MIU/M(2)/24 hours for 72 hours and famotidine 20 mg i.v. twice per day. All patients had received prior systemic therapy. Cycles were repeated every 4 weeks until disease progression.
Patient characteristics: 8 with melanoma, 8 males, median age, 64, median Eastern Cooperative Oncology Group performance status, 1; most common metastatic sites: lungs, lymph nodes, bone, and liver. Median number of cycles received=2 (range, 2-4). Most common toxicities were fever, nausea/emesis, hypomagnesemia, hypophosphatemia, hyponatremia, and rigors. All patients were treated on an oncology inpatient unit. One (1) patient with kidney cancer has had a partial response in lung and lymph nodes for 5 months, while 1 patient with melanoma had a partial response in pulmonary metastases. Cyclophosphamide and IL-2 with famotidine has evidence of antitumor activity in previously treated kidney cancer and melanoma.