Phase II Trial of Decitabine in Patients With Chronic Myelogenous Leukemia Chronic Phase Who Are Refractory to Imatinib Mesylate (Gleevec) - Full Text View

Sponsor:	SuperGen
Information provided by:	SuperGen
ClinicalTrials.gov Identifier:	NCT00042016

Purpose

To determine the safety and efficacy of decitabine in patients with Philadelphia chromosome-positive chronic myelogenous leukemia chronic phase that were previously treated with imatinib mesylate (STI 571) and became resistant/refractory or were found to be intolerant to the drug.

Condition	Intervention	Phase
Chronic Myelogenous Leukemia	Drug: decitabine (5-aza-2'deoxycytidine)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II, Multicenter Study of Decitabine (5-aza-2'Deoxycytidine) in Chronic Myelogenous Leukemia Chronic Phase Refractory to Imatinib Mesylate (STI 571)

Resource links provided by NLM:

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

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

U.S. FDA Resources

Further study details as provided by SuperGen:

Estimated Enrollment:	40
Study Start Date:	July 2002

Eligibility

Ages Eligible for Study:	2 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion:

Histologically confirmed diagnosis of CML chronic phase
Ph chromosome-positive
Previous treatment with imatinib mesylate resulting in: i) Hematologic Resistance / Hematologic Refractory: Based on a physician's (documented) decision to discontinue imatinib mesylate treatment due to failure of continued benefit or no benefit to the patient, ii) Imatinib Mesylate Intolerance: any toxicity resulting in a physician's (documented) decision to discontinue imatinib mesylate treatment.
Patients must have recovered from the side effects of previous CML therapy for chronic phase with the exception of hydroxyurea
Age >/= 2 years
Bilirubin </= 3 x the upper limit of normal (ULN), SGOT and SGPT </= 3 x ULN, except </= 5 x ULN in leukemic involvement of the liver, serum creatinine </= 2 x ULN
WHO performance status 0-3
A negative serum hCG pregnancy test in patients of childbearing potential
Able to give signed informed consent directly or through a parent or guardian for minors

Exclusion:

Leukemic involvement of the central nervous system
Active malignancy other than CML or non-melanoma cancer of the skin
Previous treatment for CML with another investigational agent within 28 days of study entry
At study entry, patients who were treated with: imatinib mesylate within the past 48 hours; interferon-alpha within the past 48 hours; homoharringtonine within the past 14 days; low-dose cytosine arabinoside within 7 days, moderate dose within 14 days, or high dose within 28 days; etoposide, anthracyclines, or mitoxantrone within 21 days; busulfan within the past six weeks
Patients who had received hematopoietic stem cell transplantation within 6 weeks of Day 1 decitabine therapy
Patients with Grade 3/4 cardiac disease or any other serious concurrent medical condition.
Patients who are pregnant or nursing. All patients of childbearing potential must practice effective methods of contraception while on study.
Patients with mental illness or other condition precluding their ability to give informed consent or to comply with study requirements
Patients with systemic, uncontrolled infections

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00042016

Locations

United States, California
Scripps Clinic
Escondido, California, United States
USC/Norris Cancer Center
Los Angeles, California, United States
City of Hope Medical Center
Duarte, California, United States
United States, Minnesota
Metro-Minnesota CCOP
St. Louis Park, Minnesota, United States
United States, New York
New York Medical College
Valhalla, New York, United States
United States, South Carolina
Liberty Hematology/Oncology
Columbia, South Carolina, United States
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada

Sponsors and Collaborators

SuperGen

More Information

No publications provided

Study ID Numbers:	DAC-014, DACO-014
Study First Received:	July 19, 2002
Last Updated:	October 12, 2009
ClinicalTrials.gov Identifier:	NCT00042016 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by SuperGen:

Chronic myelogenous leukemia
CML
CML-CP
Chronic phase
Decitabine
5-aza-2'deoxycytidine

Methylation
STI 571
Imatinib mesylate
Gleevec
BCR/ABL

Additional relevant MeSH terms:

Antimetabolites
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hematologic Diseases
Myeloproliferative Disorders
Enzyme Inhibitors
Leukemia, Myeloid
Decitabine

Protein Kinase Inhibitors
Pharmacologic Actions
Imatinib
Leukemia
Neoplasms
Therapeutic Uses
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Azacitidine
Bone Marrow Diseases

ClinicalTrials.gov processed this record on November 25, 2009