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

Sponsors and Collaborators:	M.D. Anderson Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00054431

Purpose

RATIONALE: 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.

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.

Condition	Intervention	Phase
Leukemia	Drug: decitabine Drug: imatinib mesylate	Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Imatinib Imatinib mesylate 5-Aza-2'-deoxycytidine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
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

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

Primary Outcome Measures:

Complete and partial response at 6 weeks after each course [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity at 6 weeks after each course [ Designated as safety issue: Yes ]

Estimated Enrollment:	80
Study Start Date:	January 2003

Detailed Description:

OBJECTIVES:

Determine the duration of response and response rate in patients with accelerated or blastic phase chronic myelogenous leukemia treated with imatinib mesylate and decitabine.
Determine the survival rate of patients treated with this regimen.
Determine the toxicity of this regimen in these patients.
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

DISEASE CHARACTERISTICS:

Histologically confirmed chronic myelogenous leukemia
- Philadelphia chromosome positive by cytogenetics OR fluorescent in situ hybridization
- Accelerated or non-lymphoid blastic phase

PATIENT CHARACTERISTICS:

Age

Any age

Performance status

ECOG 0-2

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Bilirubin no greater than 2 times upper limit of normal (ULN)
AST no greater than 2 times ULN

Renal

Creatinine less than 2.0 mg/dL

Cardiovascular

Normal cardiac function
No New York Heart Association class III or IV heart disease

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

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

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Other

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 at University of Texas
Houston, Texas, United States, 77030-4009

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Jean-Pierre Issa, MD

M.D. Anderson Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications of Results:

Oki Y, Kantarjian HM, Gharibyan V, Jones D, O'brien S, Verstovsek S, Cortes J, Morris GM, Garcia-Manero G, Issa JP. Phase II study of low-dose decitabine in combination with imatinib mesylate in patients with accelerated or myeloid blastic phase of chronic myelogenous leukemia. Cancer. 2007 Mar 1;109(5):899-906.

Study ID Numbers:	CDR0000270678, MDA-ID-02205, NCI-5737
Study First Received:	February 5, 2003
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00054431
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
Philadelphia chromosome positive chronic myelogenous leukemia
relapsing chronic myelogenous leukemia
childhood chronic myelogenous leukemia

Study placed in the following topic categories:

Imatinib
Philadelphia Chromosome
Blast Crisis
Leukemia
Chronic myelogenous leukemia
Hematologic Diseases

Leukemia, Myeloid, Accelerated Phase
Myeloproliferative Disorders
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Decitabine
Leukemia, Myeloid
Bone Marrow Diseases

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009