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Imatinib Mesylate and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Imatinib Mesylate and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Imatinib Mesylate and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia Clinical research trials and Imatinib Mesylate and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia medical trials occur in many of places across 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 generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Imatinib Mesylate and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia. Imatinib Mesylate and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Imatinib Mesylate and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia clinical trial. Participants oftentimes recieve the finest healthcare available for their Imatinib Mesylate and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Imatinib Mesylate and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia  Imatinib Mesylate and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia
Imatinib Mesylate and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia
For Condition: Philadelphia chromosome positive chronic myelogenous leukemia,relapsing chronic myelogenous leukemia,chronic phase chronic myelogenous leukemia
Status: Recruiting
Sponsor(s): Oregon Health and Science University , National Cancer Institute (NCI)
Synopsis: RATIONALE: Imatinib mesylate and interferon alfa may interfere with the growth of the cancer cells. Combining imatinib mesylate with interferon alfa may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining imatinib mesylate with interferon alfa in treating patients who have chronic myelogenous leukemia.
Details: OBJECTIVES: - Determine the maximum tolerated dose of interferon alfa administered with imatinib mesylate in patients with chronic phase chronic myelogenous leukemia. (Phase I closed to accrual as of 7/9/03.) - Determine the safety and tolerability of this regimen in this patient population. - Determine the complete, major, and minor cytogenetic response rates and complete hematologic response rate in patients after 6 and 12 months of treatment with this regimen. - Determine the molecular response (reverse transcriptase-polymerase chain reaction for bcr-abl) rate in patients who have a complete cytogenetic response after 6 and 12 months of treatment with this regimen. - Determine the pharmacokinetics of this regimen in these patients. OUTLINE: This is a dose-escalation, multicenter study. - Patients receive oral imatinib mesylate once daily beginning on day 1 and interferon alfa (IFN-A) subcutaneously once daily or 3 times weekly beginning on day 14. Courses repeat every 35 days for up to 1 year in the absence of disease progression or unacceptable toxicity. After completion of 1 year of therapy, patients may receive additional therapy, provided that the patient is benefiting from imatinib mesylate. IFN-A is discontinued in patients who achieve a molecular remission that is confirmed on 2 successive bone marrow samples. Imatinib mesylate is discontinued in patients who achieve and maintain a molecular remission for 2 years. Sequential dose escalation of IFN-A is followed by sequential dose escalation of imatinib mesylate. Cohorts of 3-6 patients receive escalating doses of IFN-A and then imatinib mesylate until the maximum tolerated dose (MTD) of the combination is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. - Phase II: Patients receive imatinib mesylate and IFN-A as in phase I at the established MTD. Patients are followed for 30 days. PROJECTED ACCRUAL: Approximately 3-15 patients will be accrued for the phase I portion of this study. (Phase I closed to accrual as of 7/9/03.) A total of 40 patients will be accrued for the phase II portion of the study within 3-4 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Cytogenetically confirmed chronic myelogenous leukemia (CML) - Less than 15% blasts in peripheral blood or bone marrow - Less than 30% blasts and promyelocytes in peripheral blood or bone marrow - Less than 20% basophils in blood or bone marrow - Platelet count at least 100,000/mm^3 - No leukemia beyond bone marrow, blood, liver, or spleen - No chloroma - Philadelphia (Ph) chromosome-positive CML in chronic phase - Newly diagnosed Ph chromosome-positive CML in chronic phase - Initial diagnosis within 6 months of study - No prior therapy for CML except hydroxyurea and/or anagrelide hydrochloride - No identified sibling donors where allogeneic stem cell transplantation is elected as first-line therapy PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - See Disease Characteristics Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST or ALT no greater than 2 times ULN Renal: - Creatinine no greater than 1.5 times ULN Cardiovascular: - No New York Heart Association class III or IV heart disease Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use 2 methods of effective barrier contraception during and for at least 3 months after study participation - No other serious uncontrolled medical condition - No autoimmune disease - No prior noncompliance to medical regimens or potential unreliability - No prior grade 3 or greater non-hematologic toxicity due to prior interferon (phase I [closed to accrual as of 7/9/03]) PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - No prior bone marrow or peripheral blood stem cell transplantation - At least 2 weeks since prior interferon alfa (phase I [closed to accrual as of 7/9/03]) Chemotherapy: - See Disease Characteristics - At least 1 day since prior hydroxyurea - At least 6 weeks since prior busulfan (phase I [closed to accrual as of 7/9/03] ) - At least 2 weeks since prior cytarabine (phase I [closed to accrual as of 7/9/03]) - No concurrent chemotherapy - Concurrent hydroxyurea allowed during the first 3 months of study Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified Other: - At least 4 weeks since prior investigational agents other than imatinib mesylate (phase I [closed to accrual as of 7/9/03]) - No concurrent grapefruit juice - Concurrent anagrelide hydrochloride allowed during the first 3 months of study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BrianDruker, Study Chair, Oregon Health and Science University
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095
United States
Recruiting Charles Sawyers 310-206-5585
Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Martin Tallman 312-695-4540
Cancer Institute at Oregon Health and Science University *Recruiting*
Portland, Oregon, 97239
United States
Recruiting Brian Druker 503-494-5596
Additional Information:
Study ID Numbers: CDR0000068443; OHSU-6263,NCI-2794
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00015847
Other Chronic Phase Chronic Myelogenous Leukemia Studies:
1. Interferon-alfa With or Without Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia
2. Homoharringtonine in Treating Patients With Chronic Myelogenous Leukemia
3. Interferon alfa Plus Sargramostim in Treating Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
4. Sargramostim in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Are Not in Complete Cytogenetic Remission Following Initial Treatment
5. Chemotherapy and Peripheral Stem Cell Transplantation Followed by Immunotherapy in Treating Patients With Chronic Myelogenous Leukemia
Related Studies:
Other chronic phase chronic myelogenous leukemia Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
Imatinib Mesylate and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia
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