Phase I Study of Zarnestra (R115777.USA30) and Gleevec (Imatinib Mesylate) in Chronic Phase Chronic Myelogenous Leukemia (CML)
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 make
cells become cancer. Imatinib mesylate is a drug that blocks the function of the protein
that comes from the Philadelphia chromosome. The Philadelphia chromosome is an abnormality
in chromosomes 9 and 22 that changes blood cells into leukemia cells.
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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated doses (MTD)
Every 3 months
Jorge E Cortes, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|M.D. Anderson Cancer Center||Houston, Texas 77030|