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Arsenic Trioxide and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Arsenic Trioxide and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Arsenic Trioxide and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia Clinical research trials and Arsenic Trioxide and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Arsenic Trioxide and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia. Arsenic Trioxide and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Arsenic Trioxide and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia clinical trial. Test subjects typically receive the most expert healthcare available for their Arsenic Trioxide and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > Arsenic Trioxide and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia  Arsenic Trioxide and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia
Arsenic Trioxide and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia
For Condition: Philadelphia chromosome positive chronic myelogenous leukemia,chronic phase chronic myelogenous leukemia
Status: Recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Combining chemotherapy with imatinib mesylate may kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of combining arsenic trioxide with imatinib mesylate in treating patients who have chronic phase chronic myelogenous leukemia.
Details: OBJECTIVES: - Determine the safety and tolerability of arsenic trioxide and imatinib mesylate in patients with resistant chronic phase chronic myelogenous leukemia. - Determine potential dose-limiting toxic effects in patients treated with this regimen. - Determine the pharmacokinetics of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive oral imatinib mesylate once daily and arsenic trioxide IV over 1-2 hours on days 1-5 of week 1 and then twice weekly. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 18-24 patients (at least 6 patients for phase I and at least 12 patients for phase II) will be accrued for this study .
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Cytogenetically confirmed Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia, meeting one of the following criteria: - Chronic phase - Less than 15% blasts in peripheral blood or marrow - Less than 30% blasts and promyelocytes in peripheral blood or marrow - Less than 20% basophils in blood or marrow - Platelet count at least 100,000/mm^3 (unless therapy related) - No progressive (increase of at least 10 cm in any 4 of the past 24 weeks) or existing (greater than 10 cm) splenomegaly - Complete hematologic response (CHR) - No immature myeloid cells in peripheral blood - No increased basophils in peripheral blood - WBC less than upper limit of normal (ULN) - Platelet count less than ULN - No major (less than 35% Ph+) or complete (0% Ph+) cytogenetic response after at least 6 months of imatinib mesylate - Loss of prior major cytogenetic response or failure to achieve major cytogenetic response PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - See Disease Characteristics Hepatic - Bilirubin less than 1.5 times ULN - AST or ALT less than 2.5 times ULN Renal - Creatinine less than 1.5 times ULN Cardiovascular - No New York Heart Association grade III or IV congestive heart failure - No untreated symptomatic cardiac ischemia - No underlying cardiac arrhythmia, including but not limited to any of the following: - Conduction abnormality/atrioventricular heart block - Nodal/junctional arrhythmia/dysrhythmia - Sinus bradycardia or tachycardia - Supraventricular tachycardia - Ventricular arrhythmia Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use 2 methods of effective barrier contraception during and for 3 months after study - Electrolyte levels (especially potassium and magnesium) normal (CHR patients) - No history of noncompliance that would preclude study participation - No other concurrent serious, uncontrolled medical condition - No grade 2 or greater neuropathy PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - More than 14 days since prior therapy except hydroxyurea, anagrelide hydrochloride, or imatinib mesylate - More than 28 days since prior investigational agents - No concurrent grapefruit or grapefruit juice
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RonaldPaquette, Principal Investigator, Jonsson Comprehensive Cancer Center
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
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612-9497
United States
Recruiting Kapil Bhalla 813-903-6861
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095
United States
Recruiting Charles Sawyers 310-206-5585
Additional Information:
Study ID Numbers: CDR0000269319; UCLA-0206062
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00053248
Other Chronic Phase Chronic Myelogenous Leukemia Studies:
1. Imatinib Mesylate and Decitabine in Treating Patients With Chronic Myelogenous Leukemia
2. Fludarabine and Total-Body Irradiation Followed By Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate
3. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia
4. Oblimersen Plus Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia
5. Homoharringtonine in Treating Patients With Chronic Myelogenous Leukemia
Related Studies:
Other chronic phase chronic myelogenous leukemia Clinical Trials
Other Oregon Clinical Trials
Other Portland Clinical Trials
Arsenic Trioxide and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia
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