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procedure, a small piece of tumor tissue is withdrawn through a needle under local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.
Status | Completed |
Enrollment | 102 |
Est. completion date | June 2012 |
Est. primary completion date | January 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
- 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: 1. have received interleukin-2 (IL-2); 2. 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 Eastern Cooperative Oncology Group (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, serum glutamic pyruvic transaminase (SGPT) and serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 2.5 x normal limit (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 cytotoxic chemotherapy, radiation or immunotherapy; greater than or equal to 2 weeks from prior targeted-therapy (cytostatic agents); such patients should have recovered from toxicity from the prior therapy. 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. 10. Patients should either: (a) have received sorafenib and or sunitinib and had progressive disease while receiving the drug(s) or (b) been intolerant to the drugs(s), or (c) been evaluated for therapy with sorafenib and or sunitinib and deemed to be ineligible; or (d) have been evaluated for therapy with sorafenib and or sunitinib and refused treatment. 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 central nervous system (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. Human immunodeficiency virus (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 craniospinal radiation, or total body irradiation (TBI). 6. Patients receiving other investigational drugs, or St. John's Wort (St. John's Wort can induce P450 and alter drug metabolism). 7. Common Toxicity Criteria (CTC) Grade 2 or greater motor or sensory neuropathy. 8. Known prior severe hypersensitivity reactions to agents containing Cremophor EL. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Huang H, Menefee M, Edgerly M, Zhuang S, Kotz H, Poruchynsky M, Huff LM, Bates S, Fojo T. A phase II clinical trial of ixabepilone (Ixempra; BMS-247550; NSC 710428), an epothilone B analog, in patients with metastatic renal cell carcinoma. Clin Cancer Res — View Citation
Huizing MT, Misser VH, Pieters RC, ten Bokkel Huinink WW, Veenhof CH, Vermorken JB, Pinedo HM, Beijnen JH. Taxanes: a new class of antitumor agents. Cancer Invest. 1995;13(4):381-404. Review. — View Citation
Von Hoff DD. The taxoids: same roots, different drugs. Semin Oncol. 1997 Aug;24(4 Suppl 13):S13-3-S13-10. Review. — View Citation
Wilson L, Jordan MA. Microtubule dynamics: taking aim at a moving target. Chem Biol. 1995 Sep;2(9):569-73. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response Rate | Response rate is the percentage of participants with a response assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions, Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions,progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions or the appearance of one or more new lesions, stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. | 6 weeks | No |
Secondary | Number of Participants With Adverse Events | Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. | 10 years | Yes |
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