Renal Cell Carcinoma Clinical Trial
Official title:
A Phase II Clinical Trial of BMS-247550 (NSC 710428), an Epothilone B Analog, in Renal Cell Carcinoma
This study will examine whether the experimental drug BMS 247550 (Ixabepilone) 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 National
Institutes of Health (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procedure, a small piece of tumor tissue is withdrawn through a needle under local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.
Background:
BMS-247550 (NSC 710428), (ixabepilone) is a semi-synthetic analog of the natural product
epothilone B.
The epothilones are a novel class of non-taxane microtubule-stabilizing agents obtained from
the fermentation of the cellulose degrading myxobacteria, Sorangium cellulosum.
BMS-247550 is active against cancer models that are naturally insensitive to paclitaxel or
have developed resistance to paclitaxel, both in-vitro and in-vivo.
Objectives
Establish the efficacy of the investigational agent BMS-247550 in patients with renal cell
carcinoma when administered as a one hour infusion on day 1 to 5 every 21 days.
Evaluate the plasma pharmacokinetics of BMS-247550.
Explore the pharmacodynamics of BMS-247550 using an assay that measures the amount of
endogenous tubulin in peripheral blood mononuclear cells (PBMC) that exists in the
polymerized versus the unpolymerized state.
Determine the extent to which pharmacodynamic changes are observed over a range of doses of
BMS-247550.
Determine if cross-resistance to BMS-247550 exists in patients who have previously received
sorafenib or sunitinib.
Eligibility:
Age greater than 18.
Pathological confirmation of renal cell carcinoma.
Prior chemotherapy including sorafenib and sunitinib is allowed.
Design:
Phase II study.
BMS-247550 will be administered on days 1 through 5, every 21 days.
Restaging will be done every two cycles.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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