Phase II Study of SCH66336, A Farnesyltransferase Inhibitor in Chronic Myelogenous Leukemia (CML)

• Status: Completed
• Trial end date: 2004-05-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Lonafarnib

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
• 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.