|
BMS-354825 in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Is Resistant to Imatinib Mesylate Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about BMS-354825 in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Is Resistant to Imatinib Mesylate conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. BMS-354825 in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Is Resistant to Imatinib Mesylate Clinical research trials and BMS-354825 in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Is Resistant to Imatinib Mesylate health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like BMS-354825 in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Is Resistant to Imatinib Mesylate. BMS-354825 in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Is Resistant to Imatinib Mesylate Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a BMS-354825 in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Is Resistant to Imatinib Mesylate clinical trial. Subjects frequently get the best healthcare possible for their BMS-354825 in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Is Resistant to Imatinib Mesylate condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "B" Clinical Trials Conditions > BMS-354825 in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Is Resistant to Imatinib Mesylate  BMS-354825 in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Is Resistant to Imatinib Mesylate
BMS-354825 in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Is Resistant to Imatinib Mesylate
For Condition: Philadelphia chromosome positive chronic myelogenous leukemia,chronic phase chronic myelogenous leukemia,relapsing chronic myelogenous leukemia
Status: Recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: BMS-354825 may stop the growth of cancer cells by stopping the enzymes necessary for cancer cell growth. PURPOSE: Phase I trial to study the effectiveness of BMS-354825 in treating patients who have chronic phase chronic myelogenous leukemia that is resistant to imatinib mesylate.
Details: OBJECTIVES: - Determine the maximum tolerated dose, maximum administered dose, dose-limiting toxicity, and a recommended phase II dose of BMS-354825 in patients with chronic phase chronic myelogenous leukemia who have hematologic resistance to imatinib mesylate. - Determine the safety and tolerability of this drug in these patients. - Determine the plasma pharmacokinetics of this drug in these patients. - Determine, preliminarily, the efficacy of this drug, in terms of hematologic, cytogenetic, and molecular responses in these patients. OUTLINE: This is an open-label, dose-escalation, multicenter study. Patients receive oral BMS-354825 once daily on days 1-5. Courses repeat every 7 days for at least 3 months in the absence of disease progression or unacceptable toxicity. Patients may receive further treatment in the absence of disease progression. Cohorts of 3-6 patients receive escalating doses of BMS-354825 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 20 additional patients receive treatment as in phase I at the MTD of BMS-354825. Patients are followed for at least 30 days. PROJECTED ACCRUAL: Approximately 50 patients (30 for phase I and 20 for phase II) will be accrued for this study within 12-18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of Philadelphia chromosome positive, chronic phase chronic myelogenous leukemia (CML) meeting all of the following criteria*: - Less than 15% blasts in peripheral blood and bone marrow - Less than 20% basophils in peripheral blood - Less than 30% blasts and promyelocytes in peripheral blood and bone marrow - Platelet count at least 100,000/mm^3 - No extramedullary involvement (other than liver or spleen) NOTE: *Patients who previously met the criteria for accelerated phase or blast phase CML, responded to treatment, and currently meet the criteria for chronic phase CML are eligible - Primary or acquired hematologic resistance to imatinib mesylate OR intolerance to imatinib mesylate defined as follows: - Primary hematologic resistance is defined as failure to reach complete hematologic response (CHR) with a dose of 400 mg/day continued for at least 3 months - Patients with hematological progression (i.e., WBC at least 10,000/mm^3 and rising consistently on at least 2 consecutive measurements obtained at least 14 days apart) while receiving imatinib mesylate of 400 mg/day are eligible if they have received less than 3 months of therapy - Acquired hematologic resistance is defined as achieving a CHR, but subsequently developing a rising WBC to at least 10,000/mm - WBC must be at least 10,000/mm^3 and rising on at least 2 measurements obtained at least 14 days apart with at least 1 of these measurements greater than 15,000/mm^3 - Intolerance is defined as having discontinued imatinib mesylate due to nonhematologic toxicity of any grade - CD4^+ T-cell count at least 350/mm^3 PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - At least 6 months Hematopoietic - See Disease Characteristics - No significant bleeding disorder unrelated to CML - No acquired bleeding disorder within the past year (e.g., acquired antifactor VIII antibodies) - No congenital bleeding disorders (e.g., von Willebrand disease) Hepatic - Bilirubin no greater than 1.5 mg/dL - ALT and AST no greater than 2.0 times upper limit of normal (ULN) Renal - Creatinine no greater than 1.5 times ULN - Potassium normal* - Magnesium normal* - Serum calcium or ionized calcium at least lower limit of normal NOTE: *Patients with low levels may be repleted to be eligible Cardiovascular - No uncontrolled or significant cardiovascular disease - No uncontrolled angina within the past 6 months - No congestive heart failure within the past 6 months - No myocardial infarction within the past 12 months - No history of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or torsades de pointes) - No history of second or third degree heart block (may be eligible if patient has a pacemaker) - No diagnosed or suspected congenital long QT syndrome - No prolonged QTc interval on pre-entry EKG (i.e., greater than 450 msec) - No heart rate less than 50/minute on pre-entry EKG - No uncontrolled hypertension - No vasculitis Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception for 1 month before, during, and 1 month after study participation - No gastrointestinal tract bleeding within the past 6 months - No connective tissue disorders - No other serious uncontrolled medical disorder or active infection that would impair the ability to receive study therapy - No dementia or altered mental status that would preclude giving informed consent - No evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, EKG, or clinical laboratory determinations unrelated to CML - No prisoners or patients who are compulsorily detained (e.g., involuntary incarceration for treatment of either a psychiatric or physical [e.g., infectious disease] illness) PRIOR CONCURRENT THERAPY: Biologic therapy - More than 14 days since prior interferon Chemotherapy - More than 14 days since prior cytarabine - More than 3 days since prior hydroxyurea Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - See Disease Characteristics - More than 28 days since other prior investigational or antineoplastic agents - More than 7 days since prior imatinib mesylate - At least 5 days or 5 half-lives since prior medications that inhibit platelet function, including the following: - Aspirin - Dipyridamole - Epoprostenol - Eptifibatide - Clopidogrel - Cilostazol - Abciximab - Ticlopidine - At least 5 days or 5 half-lives since prior anticoagulants such as warfarin or heparin/low molecular weight heparin (e.g., danaparoid, dalteparin, tinzaparin, enoxaparin) - At least 5 days or 5 half-lives since prior drugs accepted to have a risk of causing torsades de pointes, including the following: - Class IA antiarrhythmic agents (e.g., quinidine, procainamide, or disopyramide) - Class III antiarrhythmic agents (e.g., amiodarone, sotalol, ibutilide, or dofetilide) - Macrolide antibiotics (e.g., erythromycin or clarithromycin) - Antipsychotics (e.g., chlorpromazine, haloperidol, thioridazine, or pimozide) - Tricyclic antidepressants - Cisapride - Bepridil - Inapsine - Methadone - Arsenic - No concurrent drugs accepted to have a risk of causing torsades de pointes - No other concurrent treatment for CML - No concurrent dolasetron or droperidol - No concurrent anticoagulants - No concurrent medications that inhibit platelet function - Concurrent anagrelide for thrombocytosis due to CML allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CharlesSawyers, Principal Investigator, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095
United States
Recruiting Charles Sawyers 310-206-5585
Additional Information:
Study ID Numbers: CDR0000310142; UCLA-0303035,BMS-CA180002
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00064233
Other Relapsing Chronic Myelogenous Leukemia Studies:
1. Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia
2. Imatinib Mesylate and Cytarabine in Treating Patients With Newly Diagnosed Chronic Myeloid Leukemia
3. Bevacizumab, Idarubicin, and Cytarabine in Treating Patients With Blast Phase Chronic Myelogenous Leukemia
4. Bone Marrow Transplantation Plus Biological Therapy in Treating Patients With Chronic Myeloid Leukemia
5. Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia
Related Studies:
Other relapsing chronic myelogenous leukemia Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
BMS-354825 in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Is Resistant to Imatinib Mesylate
|
|
|
|
|
|
|
|
