A pilot study was performed at The University of Texas M, D. Anderson Cance
r Center to determine the feasibility of using thalidomide in a population
of renal-cell carcinoma patients who had progressive disease despite chemot
herapy and immunotherapy. Metastatic renal-cell carcinoma patients with ade
quate oral function were entered onto a study after signing an internal rev
iew board-approved informed consent. There were no exclusion criteria for p
rior therapy. Nineteen previously treated patients and one untreated patien
t with progressive renal-cell carcinoma received oral thalidomide as a sing
le agent, The starting dose was 200 mg and the dose was increased by 100 to
200 mg every week until it reached 1,200 mg/d, Response was assessed on th
e basis of a radiographic reduction of the metastatic sites involved. A cas
e report describing one of the patients involved in the pilot trial is incl
uded.