BMS 247550 to Treat Kidney Cancer

This study will examine whether the experimental drug BMS 247550 is an effective treatment
for kidney cancer. BMS 247550 belongs to a class of drugs called epothilones that interfere
with the ability of cancer cells to divide. In the way they kill cells, they are very
similar to a class of compounds known as the taxanes, which include the drug Taxol. Other
characteristics of the epothilones, however, enable them to work in cells that are resistant
to Taxol.

Patients 18 years of age or older with kidney cancer that has not spread to the central
nervous system (unless the brain tumor has remained stable for at least six months after
surgical or radiation treatment) may be eligible for this study. Pregnant or nursing women
may not participate. Candidates are 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 receive BMS 247550 by a 1-hour infusion into a vein for 5 consecutive days
(days 1, 2, 3, 4 and 5) of each 21-day treatment cycle. 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
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procedure, a small piece of tumor tissue is withdrawn through a needle under local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.

...