Myelogenous Leukemia, Chronic
Conditions
Keywords
Philadelphia chromosome positive CML, Myelogenous Leukemia, Chronic, Chronic Phase, Myelogenous Leukemia, Chronic, Accelerated Phase
Brief summary
The goal of this research is to see if giving the drug SCH66336 by mouth can improve the disease in patients with chronic or accelerated phase CML. The safety of this treatment will also be studied.
Detailed description
Objectives for this study are two-fold: 1. To determine the efficacy of SCH66336 in patients with chronic phase and accelerated phase CML in relation to response rate, duration of response, and survival. 2. To assess the toxicity of SCH66366 in these patients.
Interventions
DRUGSCH66336
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Philadelphia chromosome (Ph) -positive CML in chronic or accelerated phase; * Failure to respond to or intolerance to imatinib mesylate (Gleevec); * Age \>/= 16 years; * Life expectancy of \>/= 2 months; * Performance status 2 or better (Zubrod); * Adequate renal and hepatic functions (creatinine and bilirubin \</= 2 mg/dl); * Adequate cardiac function; * Not candidates for or have refused allogeneic transplantation; * Patients should not be receiving azoles (ketoconazole, itraconazole, fluconazole), macrolides, HIV protease inhibitors, cyclosporin or anti-seizure drugs (phenobarbital, phenytoin, carbamazepine), rifampin or isoniazid.
Countries
United States
Outcome results
None listed