Phase II Study of SCH66336, A Farnesyltransferase Inhibitor in Chronic Myelogenous Leukemia (CML)
Data Collection
Bronchiolitis Obliterans Syndrome+22
+ Organizing Pneumonia
+ Bone Marrow Diseases
Treatment Study
Summary
Study start date: April 30, 2001
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.13 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 16 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location