A phase II study of thalidomide in advanced metastatic renal cell carcinoma |
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Authors: | Minor David R Monroe Dana Damico Lisa A Meng Gloria Suryadevara Uma Elias Laurence |
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Affiliation: | (1) California Kidney Cancer Center, California Pacific Medical Center, San Francisco, CA;(2) Genentech Corporation, South San Francisco, CA;(3) The Department of Medicine and Cancer Research and Treatment Center, University of New Mexico Medical Center, Albuquerque, NM, USA |
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Abstract: | Objectives: To evaluate the toxicityand activity of thalidomide in patientswith advanced metastatic renal cell cancerand to measure changes of one angiogenicfactor, vascular endothelial growth factor(VEGF)165, with therapy.Patients and methods: 29 patients were enrolled on astudy of thalidomide using an intra-patientdose escalation schedule. Patients beganthalidomide at 400 mg/d and escalated astolerated to 1200 mg/d by day 54.Fifty-nine per cent of patients had hadprevious therapy with IL-2 and 52% wereperformance status 2 or 3. Systemic plasmaVEGF165 levels were measured by dualmonoclonal ELISA in 8 patients.Results: 24 patients were evaluable forresponse with one partial response of 11months duration of a patient with hepaticand pulmonary metastases (4%), one minorresponse, and 2 patients stable for over 6months. Somnolence and constipation wereprominent toxicities and most patientscould not tolerate the 1200 mg/day doselevel. Systemic plasma VEGF165 levels didnot change with therapy.Conclusion: These results are consistent with a lowlevel of activity of thalidomide in renalcell carcinoma. Administration of dosesover 800 mg/day was difficult to achieve inthis patient population, however lowerdoses were practical. The dose-responserelationship, if any, of thalidomide forrenal cell carcinoma is unclear. |
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Keywords: | angiogenesis renal cell carcinoma thalidomide Thalomid vascular endothelial growth factor VEGF |
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