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

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00038597

Collaborator

(none)

Enrollment

Location

36.2

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myelogenous Leukemia, Chronic	Drug: SCH66336	Phase 2

Detailed Description

Objectives for this study are two-fold:

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.
To assess the toxicity of SCH66366 in these patients.

Study Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 30, 2001

Actual Primary Completion Date :

May 7, 2004

Actual Study Completion Date :

May 7, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.