NIH Clinical Research Studies

Protocol Number: 02-C-0130

Active Accrual, Protocols Recruiting New Patients

Title:
A Phase II Clinical Trial of BMS-247550 (NSC710428), An Epothilone B Analog, In Patients With Renal Cell Carcinoma
Number:
02-C-0130
Summary:
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 that prevent cancer cells from replicating.

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 For this procedure, a small piece of tumor tissue is withdrawn through a needle under local anesthetic.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.

Sponsoring Institute:
National Cancer Institute (NCI)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): None

Eligibility Criteria:
INCLUSION CRITERIA:

Patients must fulfill all of the following criteria to be eligible for study admission:

1. Age greater than or equal to 18 years.

2. Histologic or cytologic confirmation of renal cell carcinoma (clear cell, type I and type II papillary, chromophobe, collecting duct and medullary). Patients should either: (a) have received IL-2; (b) have been evaluated for therapy with IL-2 and deemed to be ineligible; or (c) have been evaluated for therapy with IL-2 and refused treatment.

3. Measurable extent of disease.

4. Performance Status ECOG 0-2.

5. Life expectancy of 3 months or greater.

6. Suitable candidate for receiving planned therapy as evidenced by screening laboratory assessments of hematologic, renal, hepatic, and metabolic functions: platelet count greater than or equal to 100,000/mL, absolute granulocyte count (AGC) greater than or equal to 1,500/mL, serum creatinine less than or equal to 1.6 or a measured creatinine clearance greater than or equal to 40 ml/min, SGPT and SGOT less than or equal to 2.5 x NL, and total bilirubin less than or equal to 1.5 x NL (in patients with clinical evidence of Gilberts' disease, less than or equal to 3 x NL).

7. Greater than or equal to 4 weeks from prior radiation, or immunotherapy.

8. No serious intercurrent medical illness.

9. The ability to understand and willingness to sign a written informed consent form, and to comply with the protocol.

EXCLUSION CRITERIA:

Patients with any of the following will be excluded from study entry:

1. Pregnant or nursing women are not eligible; neither are women or men of childbearing potential unless using effective contraception as determined by the patient's physician.

2. Patients with a history of CNS metastases, because symptoms/signs of progressive disease may be confused with drug-related toxicities, unless control has been achieved with either radiation or surgical resection at least six months prior to enrollment on study.

3. Patients who are poor medical risk because of other non-malignant systemic disease or active, uncontrolled infection.

4. HIV seropositive patients. Patients infected with the HIV virus will be excluded from this trial because the effect of BMS-247550 on HIV replication and/or the immune system is unknown and may be potentially harmful.

5. Prior chemotherapy with the exception of thalidomide and CAI. Prior treatment with thalidomide or CAI is allowed.

6. Prior craniospinal radiation, or total body irradiation (TBI).

7. Patients receiving other investigational drugs, or St. John's Wort (St. John's Wort can induce P450 and alter drug metabolism).

8. CTC Grade 2 or greater motor or sensory neuropathy.

9. Known prior severe hypersensitivity reactions to agents containing Cremophor EL.

Special Instructions: Currently Not Provided
Keywords:
Kidney Cancer
Microtubules
Tubulin
Taxanes
Therapy
Recruitment Keywords:
Kidney Cancer
Renal Cell Carcinoma
Conditions:
Renal Cell Carcinoma
Investigational Drug(s):
BMS-247550
Investigational Device(s):
None

Contacts:
Antonio T. Fojo, M.D.
National Institutes of Health
Building 10
Room 12N226
10 Center Drive
Bethesda, Maryland 20892
Phone: (301) 496-4916
Fax: (301) 402-0172
Electronic Address: f4o@cu.nih.gov

Citations:
Wilson L, Jordan MA Microtubule dynamics: taking aim at a moving target Chem Biol 1995 Sep;2(9):569-73 ReviewPMID: 9383460

Huizing MT Taxanes: a new class of antitumor agents Cancer Invest 1995;13(4):381-404 Review PMID: 7627725

Von Hoff DD The taxoids: same roots, different drugs Semin Oncol 1997 Aug;24(4 Suppl 13):S13-3-S13-10 Review PMID: 9335511

Active Accrual, Protocols Recruiting New Patients

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