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Home > "E" Clinical Trials Conditions > Experimental Drug BMS-247550 to Treat Cancer  Experimental Drug BMS-247550 to Treat Cancer
Experimental Drug BMS-247550 to Treat Cancer
For Condition: Neoplasm
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will determine the dose of the experimental anticancer drug BMS-247550 that can be given safely to patients. It will examine how the body handles the drug, its side effects, and its effect on the tumor. BMS-247550 belongs to a class of drugs called epothilones. These drugs are similar to taxanes, another class, which includes paclitaxel (Taxol), used to treat several forms of cancer, such as breast, ovary and lung. This study will see if BMS-247550 is effective against cancer that does not respond to treatment with Taxol. Patients 18 years of age and older with cancer for which there is no standard therapy or in whom therapy is not successful may be eligible for this study. Candidates will have standard blood and urine tests, chest X-ray, electrocardiogram (EKG), computerized tomography (CT) scans or other X-rays, and possibly nuclear medicine tests to determine the extent of the tumor. A biopsy-surgical removal or needle aspiration of some tumor cells for microscopic examination-may be done to confirm the diagnosis and to test why the tumor is resistant to standard drug treatment. Study participants will receive BMS-247550 intravenously (through a vein) over a 60-minute period for 5 consecutive days in 21-day cycles (i.e., 5 days of drug treatment followed by 15 days without drug). Patients can have a central venous catheter placed for administration of the drug. This is a flexible plastic tube placed under the skin of the chest or neck and inserted into a major vein. The procedure is done in the operating room under local anesthetic. Patients will be hospitalized for the first 7 days of the first cycle and the first 5 days of subsequent cycles. The total number of cycles for a given patient will be determined by his or her individual medical condition. Patients will have blood tests frequently to measure BMS-247550 levels and other substances and to evaluate drug toxicity. The blood will be drawn through the central venous catheter (if one has been placed) or, alternatively, through a heparin lock-a device with a needle that remains in place in the vein to avoid the need for multiple needle sticks. Patients will also have periodic physical examinations and will be questioned about side effects of treatment. Patients who show no evidence of disease after BMS-247550 treatment will be followed periodically at NIH. Patients whose disease does not completely resolve or recurs may be offered participation in another study, if an appropriate one is available.
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 I Study is designed to establish a maximum tolerated dose (MTD), dose limiting toxicity (DLT) and a recommended Phase II dose of the investigational agent BMS-247550 when administered as a one hour infusion on day 1 to 5 (or day 1 to day 3) 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; and to examine the frequency of mutations in the Beta-tubulin isoform that is principally expressed in each patient. In addition to the evaluation of the toxicity and pharmacokinetics of BMS-247550, the study will look for evidence of clinical antineoplastic activity of this compound. Patients with neoplasms refractory to standard therapy or those for whom there is no standard therapy that is potentially curative or capable of extending life expectancy will be evaluated for study eligibility.
Eligibility:
Study Type: Interventional, Treatment, Safety
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: Age greater than or equal to 18 years. Histologic or cytologic confirmation of cancer, for which there is no known standard therapy capable of extending life expectancy. Performance Status ECOG 0-2 Life expectancy of 3 months or greater. 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/microliters, absolute granulocyte count (AGC) greater than or equal to 1,500/microliters, serum creatinine less than or equal to 1.5 mg/dl (or if greater than 1.5, measured creatinine clearance greater than or equal to 50 mL/min), SGPT and SGOT less than or equal to 2.5 x normal limit (except in patients with liver metastases in whom the abnormal SGPT and SGOT are presumed to be secondary to hepatic metastases, less than or equal to 5 x normal limit), and bilirubin less than or equal to 1.5 x normal limit (except in patients with liver metastases in whom the abnormal bilirubin is presumed to be secondary to hepatic metastases, or in patients with clinical evidence of Gilberts' disease, less than or equal to 3 x normal limit). Greater than or equal to 4 weeks from prior radiation or chemotherapy; greater than or equal to 2 weeks from prior hormonal therapy for breast cancer; greater than or equal to 4 weeks from prior hormonal therapy for prostate cancer; greater than or equal to 6 weeks from prior treatment with nitrosoureas or mitomycin. No serious intercurrent medical illness. Bidimensionally measurable disease by radiographic means or physical examination; or relevant tumor markers (i.e. CA-125 and PSA greater than or equal to 2 x the upper limit of normal). 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: Pregnant or nursing women are not eligible; neither are women of childbearing potential unless using effective contraception as determined by the patient's physician. Patients with a history of CNS malignancy, because symptoms/signs of progressive disease may be confused with drug-related toxicities. Patients who are poor medical risk because of other non-malignant systemic disease or active, uncontrolled infection. 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. Myeloablative chemotherapy followed by bone marrow or stem cell rescue within the past 4 months. Prior craniospinal radiation, or total body irradiation (TBI). Patients receiving other investigational drugs. Patients who have not received what the "general oncology community" would consider "standard therapy".
Total Enrollment: 55
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 000224; 00-C-0224
Study Start Date: September 26, 2000
Record last reviewed: June 1, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006317
Other Neoplasm Studies:
1. Induction of Suction Blisters in Patients with Urticaria, Blistering Diseases, Inflammatory Dermatoses and Neoplastic Disorders, and in Normal Volunteers
2. Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) in Patients with Advanced Cancer
3. Phase 1 Study of Imatinab (STI571) in Patients with Advanced Cancer and Liver Dysfunction
4. Clinical Manifestations and Molecular Bases of Heritable Urologic Malignant Disorders
5. Vaccination of Follicular Lymphomas with Tumor-Derived Immunoglobulin Idiotype
Related Studies:
Other Neoplasm Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Experimental Drug BMS-247550 to Treat Cancer
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