Clinical Trial: Imatinib Mesylate and Decitabine in Treating Patients With Chronic Myelogenous Leukemia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II Study of Imatinib Mesylate (Gleevec, STI-571) (NSC#716051) and Decitabine (5-AZA-2'-Deoxycitidine) (NSC#127716), in Chronic Myelogenous Leukemia in Accelerated and Blastic Phases

Brief Summary: This phase II trial is studying how well giving imatinib mesylate together with decitabine works in treating patients with accelerated or blast phase chronic myelogenous leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving imatinib mesylate together with decitabine may kill more cancer cells

Detailed Summary:

OBJECTIVES:

I. Determine the duration of response and response rate in patients with accelerated or blastic phase chronic myelogenous leukemia treated with imatinib mesylate and decitabine.

II. Determine the survival rate of patients treated with this regimen. III. Determine the toxicity of this regimen in these patients. IV. Determine the effects of this regimen on gene methylation in the leukemic cells of these patients.

OUTLINE: Patients are stratified according to prior exposure to imatinib mesylate (yes vs no).

Patients receive oral imatinib mesylate daily and decitabine IV over 1 hour daily, 5 days per week, for 2 consecutive weeks. Courses repeat every 4-6 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 20-80 patients (10-40 per stratum) will be accrued for this study within 20 months.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome:

  • Complete and partial response [ Time Frame: 6 months ]
  • Hematologic improvement [ Time Frame: Up to 1 year ]
  • Duration of response [ Time Frame: Date of documented response until relapse, assessed up to 4 years ]


Original Primary Outcome:

Current Secondary Outcome: Toxicities, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0 [ Time Frame: Up to 4 years ]

Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: February 5, 2003
Date Started: January 2003
Date Completion:
Last Updated: January 22, 2013
Last Verified: January 2013