Zarnestra and Gleevec in Chronic Phase Chronic Myelogenous Leukemia
NCT ID: NCT00040105
Last Updated: 2012-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
26 participants
INTERVENTIONAL
2002-10-31
2009-03-31
Brief Summary
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Detailed Description
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Before treatment starts, participants will have a physical exam, blood tests (About 3 tubes, 2 teaspoons each), and a bone marrow biopsy. The bone marrow will be removed with a large needle.
Participants in this study will take imatinib mesylate by mouth every day for as long as they stay on study, which means as long as it works. Participants will also take R115777 twice a day for 2 weeks. This will be repeated every 3 weeks. The amount of each of these medications that participants take will depend on when they enter the study. The doses will be slowly increased from participant to participant until the highest dose that does not cause serious side effects is found.
Participants will be asked to visit their doctor for a physical exam and measurement of vital signs. The frequency of doctor visits will vary depending on physical condition. Blood tests (about 2 teaspoons each) will be done every week during the first 3 weeks of treatment. Blood tests will then be done every 8-12 weeks for the length of the study, as needed. The blood samples will be used for routine lab tests. A bone marrow sample will also be taken to check and measure cells related to the disease every 3 months in the first year and then every 6-12 months. Participants can stay on study for as long as the treatment is considered to be beneficial. Participants will be taken off study if their disease gets worse or intolerable side effects occur.
This is an investigational study. The FDA has authorized the use of imatinib mesylate for patients with CML. It is the combination of imatinib mesylate and R115777 that is experimental. R115777 has been authorized for investigational use only. A maximum of 30 patients will take part in this study. All will be enrolled at M. D. Anderson.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Zarnestra + Gleevec
Zarnestra (R115777)
Starting Dose:
300 mg by mouth (PO) Twice daily
Gleevec (Imatinib mesylate)
Starting Dose:
300 mg By Mouth (PO) daily
Interventions
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Zarnestra (R115777)
Starting Dose:
300 mg by mouth (PO) Twice daily
Gleevec (Imatinib mesylate)
Starting Dose:
300 mg By Mouth (PO) daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have failed therapy with imatinib mesylate. Failure will be defined as: 1) patients who have failed to achieve or have lost a complete hematologic remission at 3 months from the start of therapy with imatinib mesylate, or 2) patients who have failed to achieve or have lost at least a minimal cytogenetic response after 6 months of therapy with imatinib mesylate, or 3) patients who have failed to achieve or have lost a major cytogenetic response after 12 months of therapy with imatinib mesylate
* Chronic phase will be defined by the following features: 1) blasts in peripheral blood or bone marrow \<10%, 2) basophils in PB or BM \<20%, 3) platelets \>100 x 10(9)/L, 4) absence of clonal evolution
* Patients must sign an informed consent
* Performance status \</= 2 by Zubrod scale
* Patients must have adequate hepatic functions (bilirubin \</= 2.0 mg/dl) and renal functions (creatinine \</=2 mg/dl)
* WBC \</= 30 x 10(9)/L. Patients may receive Hydroxyurea (or other similar agent) to bring the WBC below this level. Hydroxyurea (or its equivalent) must be discontinued 24 hours before the start of therapy.
* Patients of childbearing potential should practice effective methods of contraception.
Exclusion Criteria
* Pregnant and nursing females will be excluded.
16 Years
ALL
No
Sponsors
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
INDUSTRY
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Jorge E Cortes, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M.D. Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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M.D. Anderson's Website
Other Identifiers
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ID02-169
Identifier Type: -
Identifier Source: org_study_id