Spots Global Cancer Trial Database for A Pilot Study of Decitabine and Vorinostat With Chemotherapy for Relapsed ALL
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Trial Identification
Brief Title: A Pilot Study of Decitabine and Vorinostat With Chemotherapy for Relapsed ALL
Official Title: A Pilot Study of Decitabine and Vorinostat With Chemotherapy for Relapsed ALL
Study ID: NCT01483690
Study Description
Brief Summary: This is a pilot study using decitabine and vorinostat before and during chemotherapy with vincristine, dexamethasone, mitoxantrone, and peg-asparaginase in pediatric patients with acute lymphoblastic leukemia (ALL).
Detailed Description: 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.
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Childrens Hospital Los Angeles, Los Angeles, California, United States
CHOC, Orange, California, United States
UCSF School of Medicine, San Francisco, California, United States
The Children's Hospital, University of Colorado, Aurora, Colorado, United States
Children's National Medical Center, Washington, District of Columbia, United States
University of Miami Cancer Center, Miami, Florida, United States
Children's Healthcare of Atlanta, Emory University, Atlanta, Georgia, United States
Lurie Children's Hospital, Chicago, Illinois, United States
Johns Hopkins University, Baltimore, Maryland, United States
Dana Farber, Boston, Massachusetts, United States
C.S. Mott Children's Hospital, Ann Arbor, Michigan, United States
Childrens Hospital & Clinics of Minnesota, Minneapolis, Minnesota, United States
University of Minnesota Children's Hospital, Minneapolis, Minnesota, United States
Children's Mercy Hospitals and Clinics, Kansas City, Missouri, United States
New York University Medical Center, New York, New York, United States
Children's Hospital New York-Presbyterian, New York, New York, United States
Levine Children's Hospital at Carolinas Medical Center, Charlotte, North Carolina, United States
Nationwide Childrens Hospital, Columbus, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
St. Jude, Memphis, Tennessee, United States
Vanderbilt Children's Hospital, Nashville, Tennessee, United States
University of Texas at Southwestern, Dallas, Texas, United States
Cook Children's Medical Center, Fort Worth, Texas, United States
Seattle Children's Hospital, Seattle, Washington, United States
Children's Hospital at Westmead, Westmead, New South Wales, Australia
Royal Children's Hospital, Brisbane, Queensland, Australia
Sydney Children's Hospital, Sydney, , Australia
Contact Details
Name: Michael Burke, MD
Affiliation: Medical College of Wisconsin
Role: STUDY_CHAIR
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