Protocol Number: 02-C-0130
Patients 18 years of age or older with kidney cancer that has not spread to the central nervous system may be eligible for this study. Pregnant or nursing women may not participate. Candidates will be screened with various tests that may include blood and urine tests, electrocardiogram (EKG), and chest X-ray. Computerized tomography (CT) scans or X-rays, and possibly nuclear medicine studies may be done to determine the extent of disease. Participants will receive BMS 247550 intravenously (by vein) in treatment cycles of 5 consecutive days every 21 days. The drug will be given through a central venous catheter-a tube placed under the skin of the chest or neck into a major vein. The catheter is placed in the operating room under local anesthesia. Patients must stay in the NIH area near Bethesda, Maryland for 7 to 8 days during the first treatment cycle and for the 5 days of treatment in subsequent cycles. The total number of cycles will vary among patients, depending on their individual clinical situation. The drug dose may be increased gradually in subsequent cycles in patients who can tolerate such increases. In addition, participants will undergo the following tests and procedures: - Periodic physical examinations and frequent blood tests - X-ray and other imaging studies to determine if the tumor is responding to the treatment. - Tumor biopsies to confirm the diagnosis or spread of tumor and to examine the reaction of certain proteins in cancer cells to BMS 247550. Two biopsies will be done. For this procedure, a small piece of tumor tissue is withdrawn through a needle under local anesthetic. Treatment will be stopped in patients whose tumor grows while receiving BMS 247550. Patients whose tumor disappears completely will be followed at NIH periodically for examinations and tests. Patients whose disease does not completely resolve or whose disease recurs may be advised of other appropriate research protocols at NIH or, if none are available, will be returned to the care of their local doctor.
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