|
Imatinib Mesylate and 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Chronic Myelogenous Leukemia Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Imatinib Mesylate and 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Chronic Myelogenous Leukemia conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Imatinib Mesylate and 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Chronic Myelogenous Leukemia Clinical research trials and Imatinib Mesylate and 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Chronic Myelogenous Leukemia health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Imatinib Mesylate and 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Chronic Myelogenous Leukemia. Imatinib Mesylate and 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Chronic Myelogenous Leukemia Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Imatinib Mesylate and 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Chronic Myelogenous Leukemia clinical trial. Participants oftentimes recieve the most expert healthcare available for their Imatinib Mesylate and 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Chronic Myelogenous Leukemia condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "I" Clinical Trials Conditions > Imatinib Mesylate and 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Chronic Myelogenous Leukemia  Imatinib Mesylate and 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Chronic Myelogenous Leukemia
Imatinib Mesylate and 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Chronic Myelogenous Leukemia
For Condition: accelerated phase chronic myelogenous leukemia,chronic phase chronic myelogenous leukemia,relapsing chronic myelogenous leukemia,blastic phase chronic myelogenous leukemia,Philadelphia chromosome positive chronic myelogenous leukemia
Status: Recruiting
Sponsor(s): Barbara Ann Karmanos Cancer Institute , National Cancer Institute (NCI)
Synopsis: RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy such as 17-N-allylamino-17-demethoxygeldanamycin use different ways to stop cancer cells from dividing so they stop growing or die. Combining imatinib mesylate with chemotherapy may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of imatinib mesylate combined with 17-N-allylamino-17-demethoxygeldanamycin in treating patients who have chronic myelogenous leukemia.
Details: OBJECTIVES: - Determine the maximum tolerated dose and dose-limiting toxicity of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) when administered with imatinib mesylate in patients with chronic myelogenous leukemia. - Determine the pharmacokinetics of this regimen in these patients. OUTLINE: This is an open-label, nonrandomized, multicenter, dose-escalation study of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG). Patients receive oral imatinib mesylate on days 1-21 and 17-AAG IV over 1 hour on days 1, 4, 8, and 12. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of 17-AAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional cohort of 6-10 patients receives treatment at the recommended phase II dose. PROJECTED ACCRUAL: Approximately 21-42 patients will be accrued for this study within 1.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of chronic myelogenous leukemia, including any of the following phases: - Blastic phase - Greater than 30% blasts in the peripheral blood or bone marrow - Previously untreated disease OR refractory to or relapsed after most recent therapy - Accelerated phase, defined by 1 of the following: - At least 15, but less than 30%, blasts in the peripheral blood or bone marrow - At least 30% blasts and promyelocytes in the peripheral blood or bone marrow - Greater than 20% peripheral blood basophilia - Chronic phase - No major cytogenetic response (less than 65% Philadelphia chromosome negative) after 12 months of prior imatinib mesylate therapy - Philadelphia chromosome positive by routine cytogenetics PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 3 months Hematopoietic - Not specified Hepatic - Bilirubin no greater than 1.5 mg/dL - ALT and AST no greater than 2.5 times upper limit of normal Renal - Creatinine less than 1.5 mg/dL Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No known allergy to eggs - Able to swallow pills - No ongoing or active infection - No psychiatric illness or social situation that would preclude study compliance - No other concurrent uncontrolled medical illness PRIOR CONCURRENT THERAPY: Biologic therapy - No prior stem cell transplantation Chemotherapy - More than 4 weeks since prior chemotherapy (except hydroxyurea or anagrelide) (at least 6 weeks for nitrosoureas or mitomycin) Endocrine therapy - Not specified Radiotherapy - More than 4 weeks since prior radiotherapy Surgery - No prior liver, kidney, or lung transplantation - More than 14 days since prior major surgery (e.g., thoracotomy or intra-abdominal surgery) Other - Prior imatinib mesylate administered within the past 4 weeks is allowed - No concurrent therapeutic warfarin - No concurrent tacrolimus or cyclosporine as immunosuppressive agents - No other concurrent investigational agents - No concurrent combination antiretroviral therapy for HIV-positive patients - No concurrent agents that alter CYP3A4 activity, including any of the following: - Grapefruit juice - Ketoconazole - Fluconazole - Itraconazole - Erythromycin - Clarithromycin - Cimetidine - Terfenadine - Astemizole - HIV protease inhibitors (e.g., indinavir and nelfinavir)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CharlesSchiffer, Study Chair, Barbara Ann Karmanos Cancer Institute
Hillman Cancer Center at University of Pittsburgh Cancer Institute *Recruiting*
Pittsburgh, Pennsylvania, 15213-1863
United States
Recruiting Merrill Egorin 412-623-3252
Barbara Ann Karmanos Cancer Institute *Recruiting*
Detroit, Michigan, 48201-1379
United States
Recruiting Charles Schiffer 313-745-8910
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 888-NCI-1937
Additional Information:
Study ID Numbers: CDR0000315521; NCI-5932,WSU-C-2599
Study Start Date:
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066326
Other Blastic Phase Chronic Myelogenous Leukemia Studies:
1. Arsenic Trioxide in Treating Patients With Relapsed or Refractory Chronic Myelogenous Leukemia
2. Bortezomib in Treating Young Patients With Refractory or Recurrent Leukemia
3. Bevacizumab, Idarubicin, and Cytarabine in Treating Patients With Blast Phase Chronic Myelogenous Leukemia
4. Chemotherapy in Treating Children With Relapsed Acute Leukemia, Acute Myeloid Leukemia, or Blastic Phase Chronic Myelogenous Leukemia
5. STI571 Plus Cytarabine in Treating Patients With Chronic Myelogenous Leukemia
Related Studies:
Other blastic phase chronic myelogenous leukemia Clinical Trials
Other Pennsylvania Clinical Trials
Other Pittsburgh Clinical Trials
Imatinib Mesylate and 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Chronic Myelogenous Leukemia
|
|
|
|
|
|
|
|
