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Home > "P" Clinical Trials Conditions > Phase I Study of Zarnestra and Gleevec in Chronic Phase Chronic Myelogenous Leukemia  Phase I Study of Zarnestra and Gleevec in Chronic Phase Chronic Myelogenous Leukemia
Phase I Study of Zarnestra and Gleevec in Chronic Phase Chronic Myelogenous Leukemia
For Condition: Leukemia, Myeloid, Chronic
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center ,
Synopsis: The purpose of this study is to investigate the most effective dose of R115777 (Zarnestra) and imatinib mesylate (Gleevec) when used in combination, and the safety of this combination. The possible effect of this combination in Chronic Myelogenous Leukemia (CML) will also be investigated. Patients will also be asked to give a small additional amount of blood and bone marrow whenever one of these procedures is done. The purpose of this is to investigate the effect of this therapy on the leukemia cells and understand better how these drugs work together.
Details: R115777 is a new drug that blocks the function of an enzyme that is important in making some proteins work. One of the most important targets for this enzyme is a protein that can change normal cells into cancer cells. Imatinib mesylate is a drug that blocks the function of the protein that comes from the Philadelphia chromosome, an abnormality observed often in CML. The objectives to this clinical trial are: (1) to determine the maximum tolerated doses (MTD) of Zarnestra and Gleevec, when given in combination to patients with chronic phase CML; and (2)to assess the toxicity of the ZARNESTRA and Gleevec combination in these patients.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: - Patients 16 years or older with Philadelphia chromosome (Ph)-positive or BCR/ABL-positive CML (as determined by cytogenetics, FISH, or PCR) are eligible if they are not candidates for known regimens or protocol treatments of higher efficacy or priority. Patients must be in the chronic phase of CML. - Patients must have failed therapy with imatinib mesylate. Failure will be defined as: (a) Patients who have failed to achieve or lost a complete hematologic remission (i.e., normalization for at least 4 weeks of the bone marrow (less than 5% blasts) and peripheral blood with WBC < 10 x 10e9/L, platelets <450 x 10e9/L and no peripheral blasts, promyelocytes or myelocytes. This is in addition to disappearance of all signs and symptoms of the disease) after 3 months from the start of therapy with imatinib mesylate, or (b) Patients who have failed to achieve or lost at least a minimal cytogenetic response (Philadelphia-positive cells in 36-65% of the total) after 6 months of therapy with imatinib mesylate, or (c) Patients who have failed to achieve or have lost a major cytogenetic response (Philadelphia-positive cells in 0-35% of the total) after 12 months of therapy with imatinib mesylate. - Chronic phase will be defined by the following features: (a) Blasts in peripheral blood (PB) or bone marrow (BM) <10% (b) Basophils in PB or BM <20% (c) Platelets >100 x109/L (d) Absence of clonal evolution - Patients must sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital. The only acceptable consent form is attached at the end of the protocol. - Performance status
Total Enrollment: 30
Location and Contact Information:
M.D. Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Jorge Cortes 713-794-5783
Additional Information:
Study ID Numbers: ID02-169;
Study Start Date: October 2002
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00040105
Other Leukemia, Myeloid, Chronic Studies:
1. Phase I Study of Zarnestra and Gleevec in Chronic Phase Chronic Myelogenous Leukemia
2. A exploratory, open-label study of the investigational product, AG-858, in patients who are cytogenetically positive after treatment with Gleevecâ„¢.
3. Safety and Tolerability Study of FPTI in Patients With Leukemia
4. Randomized Trial of High-Dose Gleevec Alone or in Combination with Peg-Alpha Interferon and GM-CSF in Early Phase CML
5. Randomized double cord blood transplant study
Related Studies:
Other Leukemia, Myeloid, Chronic Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Phase I Study of Zarnestra and Gleevec in Chronic Phase Chronic Myelogenous Leukemia
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