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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00038597
First received: June 3, 2002
Last updated: January 20, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Myelogenous Leukemia, Chronic
Drug: SCH66336
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of SCH66336, A Farnesyltransferase Inhibitor in Chronic Myelogenous Leukemia (CML)

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Enrollment: 13
Study Start Date: April 2001
Study Completion Date: May 2004
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038597

Locations
United States, Texas
MDAnderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Jorge Cortes, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00038597     History of Changes
Other Study ID Numbers: DM01-072
Study First Received: June 3, 2002
Last Updated: January 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Philadelphia chromosome positive CML
Myelogenous Leukemia, Chronic, Chronic Phase
Myelogenous Leukemia, Chronic, Accelerated Phase

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia
Chronic Disease
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014