Imatinib Mesylate and Decitabine in Treating Patients With Chronic Myelogenous Leukemia - Full Text View

Purpose

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

Condition	Intervention	Phase
Accelerated Phase Chronic Myelogenous Leukemia Blastic Phase Chronic Myelogenous Leukemia Childhood Chronic Myelogenous Leukemia Chronic Myelogenous Leukemia, BCR-ABL1 Positive Relapsing Chronic Myelogenous Leukemia	Drug: imatinib mesylate Drug: decitabine Other: laboratory biomarker analysis	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Chronic Myeloid Leukemia Leukemia

Drug Information available for: Azacitidine Decitabine Imatinib Imatinib mesylate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Complete and partial response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Hematologic improvement [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: Date of documented response until relapse, assessed up to 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicities, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0 [ Time Frame: Up to 4 years ] [ Designated as safety issue: Yes ]

Enrollment:	80
Study Start Date:	January 2003
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Drug: imatinib mesylate Given orally Other Names: CGP 57148 Gleevec Glivec Drug: decitabine Given IV Other Names: 5-aza-dCyd 5AZA DAC Other: laboratory biomarker analysis Correlative studies

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054431

Locations

United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Jean-Pierre Issa

M.D. Anderson Cancer Center

More Information

No publications provided

Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00054431 History of Changes
Other Study ID Numbers:	NCI-2012-02516, MDA-ID-02205, N01CM62202, CDR0000270678
Study First Received:	February 5, 2003
Last Updated:	January 22, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Blast Crisis
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Accelerated Phase
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Cell Transformation, Neoplastic
Neoplastic Processes
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases

Pathologic Processes
Decitabine
Imatinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on June 13, 2013