Clinical Trial: Decitabine versus Supportive Care in Adults with Advanced-stage MDS


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Sponsored by:	SuperGen
Information provided by:	SuperGen

Condition	Treatment or Intervention	Phase
Myelodysplastic Syndrome	Drug: decitabine (5-aza-2'deoxycytidine)	Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title: A Randomized, Open-label, Phase III Trial of Decitabine (5-aza-2’deoxycytidine) versus Supportive Care in Adults with Advanced-stage Myelodysplastic Syndrome

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both

Inclusion:

MDS (de novo or secondary) fitting any of the recognized French-American-British, FAB, classifications or chronic myelomonocytic leukemia (CMML) with WBC < 12,000/mm3, AND International Prognostic Scoring System (IPSS) >/= 0.5 as determined by CBC, bone marrow assessment and bone marrow cytogenetics within 30 days of randomization
18 years or older
Female patients of child-bearing potential must have a negative serum hCG within 24 hours prior to randomization, must practice a medically approved method of birth control for the past 30 days, and agree to continue this practice for the trial duration and must not be breast-feeding
ECOG or WHO performance status of 0-2
Written informed consent
Normal renal and hepatic function (creatinine </= 2 mg/dL, bilirubin </= 1.5 mg/dL, SGPT </= 2 times the upper limit of normal range)

Exclusion:

Acute Myeloid Leukemia (AML) (>/=30% bone marrow blasts) or other progressive malignant disease
Patients must have recovered from the toxic effects of prior therapy and must be off all chemotherapy for a minimum of 4 weeks prior to study entry to the protocol (a minimum of six weeks for prior nitrosoureas and bone marrow transplantation)
Ongoing treatment with androgenic hormones, danazol, colony-stimulating factors, or other agents used to treat MDS within 7 days of study initiation.
Administration of any investigational agent within the 30 days preceding study initiation.
Uncontrolled cardiac disease or congestive heart failure
Uncontrolled restrictive or obstructive pulmonary disease
Active viral or bacterial infection
Superimposed autoimmune hemolytic anemia or thrombocytopenia
Known positive serology for HIV
Mental illness or other condition preventing full cooperation with the treatment and monitoring requirements of the study.

Jocelyn Rojas, RN 925-560-0100 Ext. 424 jrojas@supergen.com
Emel Bayar, MD 925-560-0100 Ext. 404 ebayar@supergen.com

California
Loma Linda Univ. Cancer Center, Loma Linda, California, United States; Recruiting

Chien-Shing (C.S.) Chang, MD, Principal Investigator

Alta Bates Comprehensive Cancer Center, Berkeley, California, United States; Terminated

Scripps Clinic, Escondido, California, United States; Recruiting

Richard Just, MD, Principal Investigator

City of Hope National Medical Center, Duarte, California, United States; Recruiting

Margaret O'Donnell, MD, Principal Investigator

Univ. California San Francisco Medical School, San Francisco, California, United States; Recruiting

Thomas Martin, MD, Principal Investigator

Florida
University of Florida, Gainsville, Florida, United States; Recruiting

Kataryzna Finiewicz, MD, Principal Investigator

James A. Haley Veteran's Hospital, Tampa, Florida, United States; Recruiting

Hussain Saba, MD, PhD, Principal Investigator

H. Lee Moffitt Cancer Center, Tampa, Florida, United States; Recruiting

Hussain Saba, MD, PhD, Principal Investigator

Illinois
University of Illinois at Chicago, Chicago, Illinois, United States; Recruiting

Farhad Ravandi, MD, Principal Investigator

Rush Medical Center, Chicago, Illinois, United States; Recruiting

Azra Raza, MD, Principal Investigator

Massachusetts
Dana Farber Cancer Institute, Boston, Massachusetts, United States; Recruiting

Daniel DeAngelo, MD, PhD, Principal Investigator

New England Medical Center Hospital, Boston, Massachusetts, United States; Recruiting

Kenneth Miller, MD, Principal Investigator

University of Massachusetts Medical School, Worcester, Massachusetts, United States; Recruiting

Peter Westervelt, MD, Principal Investigator

Minnesota
VA Medical Center, Minneapolis, Minnesota, United States; Recruiting

Pankaj Gupta, MD, Principal Investigator

Missouri
Washington Univ. School of Medicine, St. Louis, Missouri, United States; Recruiting

John DiPersio, MD, PhD, Principal Investigator

New York
Memorial Sloan Kettering Cancer Center, New York, New York, United States; Recruiting

Virginia Klimek, MD, Principal Investigator

Mount Sinai Medical Center, New York, New York, United States; Recruiting

Louis Silverman, MD, Principal Investigator

Roswell Park Cancer Institute, Buffalo, New York, United States; Recruiting

James Slack, MD, Principal Investigator

North Carolina
Duke University Medical Center, Durham, North Carolina, United States; Recruiting

Carlos deCastro, MD, Principal Investigator

UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States; Recruiting

Beverly Mitchell, MD, Principal Investigator

Tennessee
The Memphis Cancer Center, Memphis, Tennessee, United States; Recruiting

Donald Strickland, MD, Principal Investigator

Texas
SW Regional Cancer Center (dba Central Texas Oncology Associates), Austin, Texas, United States; Recruiting

Richard Helmer, MD, Principal Investigator

MD Anderson Cancer Center, Houston, Texas, United States; Recruiting

Jean-Pierre Issa, MD, Principal Investigator

Texas Oncology, Dallas, Texas, United States; Recruiting

Craig Rosenfeld, MD, Principal Investigator