Spots Global Cancer Trial Database for Entinostat in Treating Pediatric Patients With Recurrent or Refractory Solid Tumors
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Entinostat in Treating Pediatric Patients With Recurrent or Refractory Solid Tumors
Official Title: A Phase 1 Study of Entinostat, an Oral Histone Deacetylase Inhibitor, in Pediatric Patients With Recurrent or Refractory Solid Tumors, Including CNS Tumors and Lymphoma
Study ID: NCT02780804
Conditions
Study Description
Brief Summary: This phase I trial studies the side effects and best dose of entinostat in treating pediatric patients with solid tumors that have come back or have not responded to treatment. Entinostat may block some of the enzymes needed for cell division and it may help to kill tumor cells.
Detailed Description: PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) and/or recommended phase 2 dose of entinostat administered as a single-agent, once weekly to children with recurrent or refractory solid tumors. II. To define and describe the toxicities of entinostat administered as a single agent, once weekly to children with recurrent or refractory solid tumors. III. To characterize the pharmacokinetics of entinostat in children with recurrent or refractory cancer. SECONDARY OBJECTIVES: I. To preliminarily define the antitumor activity of entinostat within the confines of a phase 1 study. II. To assess change in histone H3 and H4 acetylation in peripheral blood mononuclear cells (PBMCs) as a marker of the biologic activity of entinostat. OUTLINE: This is a dose escalation study. Patients receive entinostat orally (PO) on days 1, 8, 15, and 22. Cycles repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.
Keywords
Eligibility
Minimum Age: 12 Months
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital of Alabama, Birmingham, Alabama, United States
Children's Hospital Los Angeles, Los Angeles, California, United States
Children's Hospital of Orange County, Orange, California, United States
UCSF Medical Center-Mission Bay, San Francisco, California, United States
Children's Hospital Colorado, Aurora, Colorado, United States
Children's National Medical Center, Washington, District of Columbia, United States
Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia, United States
Lurie Children's Hospital-Chicago, Chicago, Illinois, United States
Riley Hospital for Children, Indianapolis, Indiana, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
C S Mott Children's Hospital, Ann Arbor, Michigan, United States
University of Minnesota/Masonic Cancer Center, Minneapolis, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York, New York, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States
Saint Jude Children's Research Hospital, Memphis, Tennessee, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston, Texas, United States
Seattle Children's Hospital, Seattle, Washington, United States
Contact Details
Name: Andrew Bukowinski
Affiliation: COG Phase I Consortium
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
