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| |  CFS: Thalidomide Shows Promise in Treatment of Renal Cell Carcinoma By Rabiya S. Tuma Special to DG News NEW YORK, NY -- November 15, 2002 -- Single-agent thalidomide therapy elicits partial responses and stable disease in a significant number of patients with renal cell carcinoma. Dr. Robert Amato, from the Scott Department of Urology at Baylor College of Medicine in Houston, Texas, United States, presented a summary of published phase II thalidomide trials, as well as new data on phase I/II combination regimens for renal cell carcinoma, at the Chemotherapy Foundation Symposium here November 14. Summarising data from nine phase II trials, Dr. Amato said thalidomide as a single agent produced a 0-17 percent partial response rate and stable disease in 17-64 percent of the 183 patients treated at various centers. Remarkably, more than 40 percent of the patients with stable disease have remained in that state for 14 months or longer. However, thalidomide as a single agent has not induced a complete response in any patient. Based on the phase II studies, researchers have settled on a dose of 400-600 mg daily for single agent therapy and have started to test the drug in combination therapies. Two trials the Baylor group is involved in are testing thalidomide with interferon alpha and capecitabine and thalidomide with IL-2. "In combinations, it appears to be additive with the interferon combination or with the IL-2 in the small number of patients tested, which is why the bigger trials are taking place at multiple centers," Dr. Amato told Doctor's Guide. The additivity of such combinations makes sense in light of the fact that thalidomide works both as an inhibitor of angiogenesis and as an immune modulator. Thus, by combining it with IL-2, which stimulates the immune system, the effects of thalidomide may be bolstered. Fifteen patients enrolled in the thalidomide-IL-2 double-agent phase I trial at Baylor. They received 7 mIu/m2 IL-2 and 200 to 600 mg thalidomide daily on a increasing dose schedule. Of these patients, two showed a complete response, four had a partial response and two had stable disease. In a subsequent phase II trial of the IL-2 thalidomide combination, 37 patients enrolled. At this point, four are too early to evaluate. Of the remaining 33, two have complete response, seven have a partial response and ten showed stable disease, including some for as long as fifteen months. Given these promising phase II data, Amato and colleagues at several other centers will initiate a phase III trial to compare the combination of thalidomide and IL-2 to both drugs as single agents. They will begin enrolling patients in early 2003 and aim for a total of 450 individuals for the trial.
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