A Pilot Study of Decitabine and Vorinostat With Chemotherapy for Relapsed ALL
Decitabine is a demethylating agent and vorinostat is a HDAC inhibitor. The use of
demethylating agents and HDAC inhibitors in combination have been previously shown to have
synergistic effects in altering neoplastic pathways of cancer cells and be well tolerated in
human clinical studies. With the ability of decitabine and vorinostat to alter the abnormal
cellular pathways of leukemic blasts and essentially turn off anti-apoptotic proteins, the
leukemia cells have become primed for cytotoxic cell kill via chemotherapeutic agents. This
study will ask the question as to whether or not the combination of decitabine and
vorinostat followed by chemotherapy is feasible and whether it can positively impact outcome
in patients with relapsed or refractory acute lymphoblastic leukemia.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of participants with adverse events.
To evaluate the side effects of giving decitabine and vorinostat before and during chemotherapy using the standard drugs vincristine, dexamethasone, PEG-asparaginase and mitoxantrone.
6 weeks
Yes
Michael Burke, MD
Study Chair
University of Minnesota Children's Hospital
United States: Food and Drug Administration
T2009-003
NCT01483690
December 2011
Name | Location |
---|---|
Johns Hopkins University | Baltimore, Maryland 21205 |
Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
Stanford University Medical Center | Stanford, California 94305-5408 |
Children's National Medical Center | Washington, District of Columbia 20010-2970 |
Phoenix Children's Hospital | Phoenix, Arizona 85016-7710 |
Children's Hospital Central California | Madera, California 93638-8762 |
Childrens Hospital Los Angeles | Los Angeles, California 90027 |
Vanderbilt Children's Hospital | Nashville, Tennessee 37232-6310 |
New York University Medical Center | New York, New York 10016 |
Oregon Health and Science University | Portland, Oregon 97201 |
Seattle Children's Hospital | Seattle, Washington 98105 |
Children's Mercy Hospitals and Clinics | Kansas City, Missouri 64108 |
Memorial Sloan Kettering | New York, New York 10021 |
Cook Children's Medical Center | Fort Worth, Texas 76104 |
Dana Farber | Boston, Massachusetts 02115-6084 |
UCSF School of Medicine | San Francisco, California 94143-0106 |
University of Miami Cancer Center | Miami, Florida 33136 |
C.S. Mott Children's Hospital | Ann Arbor, Michigan 48109-0914 |
Childrens Hospital & Clinics of Minnesota | Minneapolis, Minnesota 55404-4597 |
Children's Hospital New York-Presbyterian | New York, New York 10032 |
Miller Children's Hospital | Long Beach, California 90806 |
Children's Memorial | Chicago, Illinois 60614 |
Oakland Children's Hospital | Oakland, California |
University of Minnesota Children's Hospital | Minneapolis, Minnesota |
Nationwide Childrens Hospital | Columbus, Ohio |
Levine Children's Hospital at Carolinas Medical Center | Charlotte, North Carolina 28203 |
Children's Healthcare of Atlanta, Emory University | Atlanta, Georgia |
St. Jude | Memphis, Tennessee 38105-3678 |
The Children's Hospital, University of Colorado | Aurora, Colorado 80045 |
University of Texas at Southwestern | Dallas, Texas |