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Oblimersen Plus Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Oblimersen Plus Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Oblimersen Plus Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia Clinical research trials and Oblimersen Plus Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Oblimersen Plus Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia. Oblimersen Plus Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Oblimersen Plus Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia clinical trial. Subjects typically recieve the finest healthcare available for their Oblimersen Plus Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "O" Clinical Trials Conditions > Oblimersen Plus Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia  Oblimersen Plus Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia
Oblimersen Plus Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia
For Condition: chronic phase chronic myelogenous leukemia,Philadelphia chromosome positive chronic myelogenous leukemia,relapsing chronic myelogenous leukemia
Status: Recruiting
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI)
Synopsis: RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Oblimersen may help imatinib mesylate kill more cancer cells by making cancer cells more sensitive to the drug. PURPOSE: Phase II trial to study the effectiveness of combining oblimersen with imatinib mesylate in treating patients who have chronic myelogenous leukemia that has not responded to previous treatment with imatinib mesylate.
Details: OBJECTIVES: - Determine the cytogenetic response rate of patients with imatinib mesylate-resistant chronic myelogenous leukemia treated with oblimersen and imatinib mesylate. - Determine the hematologic and molecular response rate and duration of patients treated with this regimen. - Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive oblimersen IV continuously on days 1-10 and oral imatinib mesylate once or twice daily. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients without a hematologic response after 2 courses go off study. Patients with complete or partial response after 4 courses may continue to receive oral imatinib mesylate daily. Patients in cohort 2 receive an escalated dose of oblimersen; if well tolerated, subsequent cohorts receive oblimersen at the higher dose with the original dose of imatinib mesylate. If oblimersen is not well tolerated in cohort 2, subsequent cohorts receive the original dose of oblimersen with an escalated dose of imatinib mesylate. The first 6 patients accrued continue to receive the original dose (dose taken prior to study) of imatinib mesylate throughout the study. Patients are followed monthly for 3 months and then every 3 months for 5 years. PROJECTED ACCRUAL: A total of 12-43 patients will be accrued for this study within 6 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 15 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of chronic myelogenous leukemia in chronic phase - Refractory to prior imatinib mesylate by the following criteria: - At least 400 mg/day for more than 8 weeks without a complete hematologic response or more than 6 months without a major cytogenetic response - No evidence of disease progression to accelerated or blast phases - Must have received stable dose (at least 600 mg/day) of imatinib mesylate for at least 4 weeks without grade 2 or greater toxic effects - If Philadelphia chromosome t(9;22) or a variant translocation is not detectable, then patients must meet 1 of the following: - Polymerase chain reaction positive fusion transcripts for BCR/ABL - BCR/ABL translocation present by fluorescence in situ hybridization - Must also be registered on CLB-9665 and CLB-29801 PATIENT CHARACTERISTICS: Age - 15 and over Performance status - Not specified Life expectancy - At least 2 years Hematopoietic - Not specified Hepatic - Bilirubin no greater than 2 mg/dL - AST no greater than 1.5 times upper limit of normal (ULN) - PTT no greater than 1.5 times ULN Renal - Creatinine no greater than 2 mg/dL Cardiovascular - No uncontrolled cardiovascular disease Pulmonary - No pulmonary disease that would preclude study participation Other - No other concurrently active malignancy except nonmelanoma skin cancer (i.e., completed therapy and considered to be at less than 30% risk of relapse within 1 year) - No diabetes - No infection - No other serious illness that would limit life expectancy - No psychiatric condition that would preclude study participation - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception during and for at least 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy - No prior stem cell transplantation - At least 4 weeks since prior interferon Chemotherapy - At least 4 weeks since prior hydroxyurea, homoharringtonine, or cytarabine - No other prior antineoplastic agents (e.g., busulfan) - No concurrent chemotherapy Endocrine therapy - No concurrent hormones except for steroids for adrenal failure or drug-related rash or hormones for nondisease-related conditions (e.g., insulin for diabetes or estrogens for osteopenia) Radiotherapy - No concurrent palliative radiotherapy Surgery - No concurrent surgical splenectomy except for traumatic injury, unresponsive infarction, emergency management, or splenic hemorrhage Other - At least 4 weeks since prior investigational agents - At least 4 weeks since prior anagrelide - No concurrent oral anticoagulants
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MeirWetzler, Study Chair, Roswell Park Cancer Institute
Lenoir Memorial Hospital Cancer Center *Recruiting*
Kinston, North Carolina, 28503-1678
United States
Recruiting Peter Watson 919-559-2200 Ext. 201
Oncology and Hematology Associates of Southwest Virginia, Inc. *Recruiting*
Roanoke, Virginia, 24014
United States
Recruiting Paul Richards 540-982-0237
New York Weill Cornell Cancer Center at Cornell University *Recruiting*
New York City, New York, 10021
United States
Recruiting Scott Wadler 212-746-2844
Broward General Medical Center *Recruiting*
Ft. Lauderdale, Florida, 33316
United States
Recruiting Luis Barreras 954-771-0692
FirstHealth Moore Regional Hospital *Recruiting*
Pinehurst, North Carolina, 28374
United States
Recruiting Ellen Willard 910-295-9205
NorthEast Oncology Associates *Recruiting*
Concord, North Carolina, 28025
United States
Recruiting James Wall 704-783-1370
CCOP - Kansas City *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Jorge Paradelo 816-823-0555
Louis A. Weiss Memorial Hospital *Recruiting*
Chicago, Illinois, 60640
United States
Recruiting Keith Shulman 773-564-5022
Florida Hospital Cancer Institute *Recruiting*
Orlando, Florida, 32804
United States
Recruiting Jane Crofton 407-303-2090
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1082
United States
Recruiting David Hurd 336-716-2088
Palm Beach Cancer Institute *Recruiting*
West Palm Beach, Florida, 33401
United States
Recruiting Robert Jacobson 561-366-4150
Northeast Alabama Regional Medical Center *Recruiting*
Anniston, Alabama, 36207
United States
Recruiting Thomas Twele 256-236-2549
New Hanover Regional Medical Center *Recruiting*
Wilmington, North Carolina, 28402-9025
United States
Recruiting Cyrus Kotwall 910-763-4630
Roswell Park Cancer Institute *Recruiting*
Buffalo, New York, 14263-0001
United States
Recruiting Ellis Levine 716-845-8547
CCOP - Illinois Oncology Research Association *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
Baptist Hospital East - Louisville *Recruiting*
Louisville, Kentucky, 40207
United States
Recruiting Daniel Scullin 502-897-1166
New Hampshire Oncology-Hematology, PA - Hooksett *Recruiting*
Hooksett, New Hampshire, 03106
United States
Recruiting Douglas Weckstein 603-622-6484
Cape Fear Valley Health System *Recruiting*
Fayetteville, North Carolina, 28302-2000
United States
Recruiting Kamal Bakri 910-609-6910
Veterans Affairs Medical Center - Asheville *Recruiting*
Asheville, North Carolina, 28805
United States
Recruiting John Lucke 828-299-2540
University of Puerto Rico School of Medicine Medical Sciences Campus *Recruiting*
San Juan, , 00936-5067
Puerto Rico
Recruiting Enrique Velez-Garcia 787-754-0101 Ext.2020
Queens Cancer Center of Queens Hospital *Recruiting*
Jamaica, New York, 11432
United States
Recruiting Hans Grunwald 718-883-4118
Fort Wayne Medical Oncology and Hematology, Incorporated *Recruiting*
Ft. Wayne, Indiana, 46885-5099
United States
Recruiting Sreenivasa Nattam 219-484-8830
Veterans Affairs Medical Center - Washington, DC *Recruiting*
Washington D.C., District of Columbia, 20422
United States
Recruiting Steven Krasnow 202-745-8178
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center *Recruiting*
Oklahoma City, Oklahoma, 73104
United States
Recruiting Howard Ozer 405-271-4022
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting Karen Wendling 773-834-7424
Veterans Affairs Medical Center - San Diego *Recruiting*
San Diego, California, 92161
United States
Recruiting Saeeda Kirmani 619-552-8585 ext. 3356
Veterans Affairs Medical Center - Las Vegas *Recruiting*
Las Vegas, Nevada, 89106
United States
Recruiting Chitha Hulugalle 702-696-3000
Martha Jefferson Hospital *Recruiting*
Charlottesville, Virginia, 22902
United States
Recruiting Stefan Gorsch 434-982-8410
St. Mary's Medical Center *Recruiting*
Huntington, West Virginia, 25701
United States
Recruiting Gerrit Kimmey 304-528-4645
West Suburban Center for Cancer Care *Recruiting*
River Forest, Illinois, 60305
United States
Recruiting John Showel 708-763-2700
Memorial Regional Hospital Comprehensive Cancer Center *Recruiting*
Hollywood, Florida, 33021
United States
Recruiting Atif Hussein 954-986-6363
Saint Anthony Medical Center *Recruiting*
Rockford, Illinois, 61108
United States
Recruiting Richard Nora 815-227-2273
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph *Recruiting*
Saint Joseph, Michigan, 49085
United States
Recruiting Eric Lester 269-982-4963
Virginia Oncology Associates - Norfolk *Recruiting*
Norfolk, Virginia, 23502
United States
Recruiting Paul Conkling 757-466-8683
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting George Canellos 617-632-3470
Veterans Affairs Medical Center - Dallas *Recruiting*
Dallas, Texas, 75216
United States
Recruiting Barry Levinson 214-648-4193
Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus, Ohio, 43210-1240
United States
Recruiting Clara Bloomfield 614-293-7518
Cooper University Hospital *Recruiting*
Camden, New Jersey, 08103
United States
Recruiting Edison Catalano 856-342-2506
Elmhurst Hospital Center *Recruiting*
Elmhurst, New York, 11373
United States
Recruiting Vladimir Benisovich 718-334-3723
Additional Information:
Study ID Numbers: CDR0000257816; CALGB-10107
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049192
Other Philadelphia Chromosome Positive Chronic Myelogenous Leukemia Studies:
1. Bevacizumab, Idarubicin, and Cytarabine in Treating Patients With Blast Phase Chronic Myelogenous Leukemia
2. Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia
3. STI571 Plus Cytarabine in Treating Patients With Chronic Myelogenous Leukemia
4. Chemotherapy and Biological Therapy in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia
5. Interferon alfa in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia
Related Studies:
Other Philadelphia chromosome positive chronic myelogenous leukemia Clinical Trials
Other Illinois Clinical Trials
Other Peoria Clinical Trials
Oblimersen Plus Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia
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