Spots Global Cancer Trial Database for A Study Of Panobinostat In Children With Refractory Hematologic Malignancies
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Trial Identification
Brief Title: A Study Of Panobinostat In Children With Refractory Hematologic Malignancies
Official Title: A Phase I Dose Finding Study Of Panobinostat In Children With Refractory Hematologic Malignancies
Study ID: NCT01321346
Study Description
Brief Summary: This study is for patients with relapsed or refractory Acute Lymphoblastic Leukemia (ALL), Acute Myelogenous Leukemia (AML), Hodgkin's Disease (HD) or Non-Hodgkin's Lymphoma (NHL). Panobinostat is a new drug that is considered investigational because it has not been approved in the United States by the Food and Drug Administration (FDA), or in any other country. Panobinostat is a histone deacetylase inhibitor (HDACi) and interferes with gene expression found in cells causing them to stop growing or die. Panobinostat has been used in several hundred adults who had leukemia, HD, NHL and other solid tumors. Panobinostat has not been given to children. This is a phase I study. In a phase I study, drugs are tested to the highest dose that can be safely given. Drugs are given at gradually increasing dosages until there are unacceptable side effects. The goal of the Phase I study is to find out the dose of panobinostat that can be safely given to children with relapsed ALL, AML, HD and NHL.
Detailed Description:
Eligibility
Minimum Age: 8 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Childrens Hospital Los Angeles, Los Angeles, California, United States
UCSF School of Medicine, San Francisco, California, 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
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
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
Rainbow Babies, Cleveland, Ohio, United States
Nationwide Childrens Hospital, Columbus, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
St. Jude, Memphis, Tennessee, United States
Vanderbilt Children's Hospital, Nashville, Tennessee, United States
Primary Children's, Salt Lake City, Utah, United States
Seattle Children's Hospital, Seattle, Washington, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: Julio Barredo, MD
Affiliation: University of Miami
Role: STUDY_CHAIR
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