Imatinib Mesylate and Decitabine in Treating Patients With Chronic Myelogenous Leukemia

NCT ID: NCT00054431

Last Updated: 2013-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31

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 Description

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.

Conditions

Accelerated Phase Chronic Myelogenous Leukemia; Blastic Phase Chronic Myelogenous Leukemia; Childhood Chronic Myelogenous Leukemia; Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Relapsing Chronic Myelogenous Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (imatinib mesylate, decitabine)

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.

Group Type: EXPERIMENTAL

imatinib mesylate

Intervention Type: DRUG

Given orally

decitabine

Intervention Type: DRUG

Given IV

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

imatinib mesylate

Given orally

Intervention Type: DRUG

decitabine

Given IV

Intervention Type: DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

CGP 57148; Gleevec; Glivec; 5-aza-dCyd; 5AZA; DAC

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed chronic myelogenous leukemia

• Philadelphia chromosome positive by cytogenetics OR fluorescent in situ hybridization
• Accelerated or non-lymphoid blastic phase
• Performance status - ECOG 0-2
• Bilirubin no greater than 2 times upper limit of normal (ULN)
• AST no greater than 2 times ULN
• Creatinine less than 2.0 mg/dL
• Normal cardiac function
• No New York Heart Association class III or IV heart disease
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No prior decitabine
• At least 2 weeks since other prior chemotherapy (unless there is evidence of rapidly progressive disease) and recovered
• Concurrent hydroxyurea allowed during the first 2 courses of study therapy in patients with rapidly progressing disease
• Prior imatinib mesylate allowed

• Patients who received at least 4 weeks of prior imatinib mesylate must have failed therapy, as evidenced by resistance after 8 weeks or disease progression
• No concurrent grapefruit or grapefruit juice

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Pierre Issa

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

MDA-ID-02205

Identifier Type: -

Identifier Source: secondary_id

N01CM62202

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000270678

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02516

Identifier Type: -

Identifier Source: org_study_id