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

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.

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Key information

Conditions

Myelogenous Leukemia, Chronic Bone Marrow Diseases Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Chronic Disease Disease Attributes Graft vs Host Disease Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Chronic-Phase Lung Diseases Lung Diseases, Obstructive Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Organizing Pneumonia Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

MDAnderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SCH66336

Drug

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start: 2001
Primary completion: 2004
Study completion: 2004
First posted: Jun 4, 2002
Registry last updated: Oct 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed