|
BMS 247550 to Treat Kidney Cancer Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on BMS 247550 to Treat Kidney Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. BMS 247550 to Treat Kidney Cancer Clinical research trials and BMS 247550 to Treat Kidney Cancer healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like BMS 247550 to Treat Kidney Cancer. BMS 247550 to Treat Kidney Cancer Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a BMS 247550 to Treat Kidney Cancer clinical trial. Human subjects often obtain the finest healthcare possible for their BMS 247550 to Treat Kidney Cancer condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "B" Clinical Trials Conditions > BMS 247550 to Treat Kidney Cancer  BMS 247550 to Treat Kidney Cancer
BMS 247550 to Treat Kidney Cancer
For Condition: Renal Cell Carcinoma
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: 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.
Details: BMS-247550 (NSC 710428) 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 has been developed by Bristol-Myers Squibb for its use in the treatment of cancer. 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. This Phase II Study is designed to 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. Other objectives are to evaluate the plasma pharmacokinetics of BMS-247550, and to 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.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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.
Total Enrollment: 114
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Antonio Fojo 3014964916
Additional Information:
Study ID Numbers: 020130; 02-C-0130
Study Start Date: February 17, 2002
Record last reviewed: February 1, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030992
Other Renal Cell Carcinoma Studies:
1. SU-011,248 in the Treatment of Patients with Cytokine-Refractory Metastatic Renal Cell Carcinoma
2. Survival Study Of Oncophage® vs. Observation In Patients with Kidney Cancer
3. Trial to Compare the Routes of Administration of an Investigational, Personalized, Therapeutic Cancer Vaccine Oncophage (HSPPC-96) in Patients with Metastatic Renal Cell Carcinoma
4. Stem Cell Transplant for Advanced Renal Cell Cancer
5. Active Immunotherapy Of Metastatic Renal Cell Carcinoma Using Autologous Dendritic Cells Transfected With Autologous Total Tumor RNA
Related Studies:
Other Renal Cell Carcinoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
BMS 247550 to Treat Kidney Cancer
|
|
|
|
|
|
|
|
