Spots Global Cancer Trial Database for Trametinib in Treating Patients With Relapsed or Refractory Juvenile Myelomonocytic Leukemia
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Trial Identification
Brief Title: Trametinib in Treating Patients With Relapsed or Refractory Juvenile Myelomonocytic Leukemia
Official Title: A Phase 2 Study of the MEK Inhibitor Trametinib (NSC# 763093) in Children With Relapsed or Refractory Juvenile Myelomonocytic Leukemia
Study ID: NCT03190915
Study Description
Brief Summary: This phase II trial studies how well trametinib works in treating patients with juvenile myelomonocytic leukemia that has come back (relapsed) or does not respond to treatment (refractory). Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed Description: PRIMARY OBJECTIVE: I. To determine the objective response rate to trametinib in children with recurrent or refractory juvenile myelomonocytic leukemia (JMML). SECONDARY OBJECTIVES: I. To further define and describe the toxicities of single agent trametinib in children with recurrent or refractory JMML. II. To further characterize the pharmacokinetics of trametinib in children with recurrent or refractory JMML. III. To prospectively evaluate mutant allele burden as a marker of disease activity in JMML. IV. To measure the rate of complete responses in children with recurrent or refractory JMML. V. To measure the duration of response among responders. EXPLORATORY OBJECTIVE: I. To describe the distribution of JMML diagnostic criteria in children with recurrent or refractory JMML. OUTLINE: Patients receive trametinib orally (PO) once daily (QD) on days 1-28 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a bone marrow aspiration or biopsy at baseline, on day 28 of cycles 1 and 2, at all subsequent odd numbered cycles, and at end of treatment. After completion of study treatment, patients are followed up annually for up to 5 years.
Keywords
Eligibility
Minimum Age: 1 Month
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital of Alabama, Birmingham, Alabama, United States
Phoenix Childrens Hospital, Phoenix, Arizona, United States
Arkansas Children's Hospital, Little Rock, Arkansas, United States
Kaiser Permanente Downey Medical Center, Downey, California, United States
Loma Linda University Medical Center, Loma Linda, California, United States
Kaiser Permanente-Oakland, Oakland, California, United States
Children's Hospital of Orange County, Orange, California, United States
Lucile Packard Children's Hospital Stanford University, Palo Alto, California, United States
UCSF Medical Center-Mission Bay, San Francisco, California, United States
Children's Hospital Colorado, Aurora, Colorado, United States
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center, Denver, Colorado, United States
Connecticut Children's Medical Center, Hartford, Connecticut, United States
Alfred I duPont Hospital for Children, Wilmington, Delaware, United States
MedStar Georgetown University Hospital, Washington, District of Columbia, United States
Children's National Medical Center, Washington, District of Columbia, United States
Nemours Children's Clinic-Jacksonville, Jacksonville, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States
Nicklaus Children's Hospital, Miami, Florida, United States
Arnold Palmer Hospital for Children, Orlando, Florida, United States
Nemours Children's Hospital, Orlando, Florida, United States
Saint Joseph's Hospital/Children's Hospital-Tampa, Tampa, Florida, United States
Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia, United States
Lurie Children's Hospital-Chicago, Chicago, Illinois, United States
Saint Jude Midwest Affiliate, Peoria, Illinois, United States
Riley Hospital for Children, Indianapolis, Indiana, United States
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
C S Mott Children's Hospital, Ann Arbor, Michigan, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis, Minneapolis, Minnesota, United States
University of Minnesota/Masonic Cancer Center, Minneapolis, Minnesota, United States
Children's Mercy Hospitals and Clinics, Kansas City, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
The Steven and Alexandra Cohen Children's Medical Center of New York, New Hyde Park, New York, United States
Mount Sinai Hospital, New York, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York, New York, United States
Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
Dayton Children's Hospital, Dayton, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, 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
BI-LO Charities Children's Cancer Center, Greenville, South Carolina, United States
Saint Jude Children's Research Hospital, Memphis, Tennessee, United States
The Children's Hospital at TriStar Centennial, Nashville, Tennessee, United States
Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States
Dell Children's Medical Center of Central Texas, Austin, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston, Texas, United States
Methodist Children's Hospital of South Texas, San Antonio, Texas, United States
Primary Children's Hospital, Salt Lake City, Utah, United States
Seattle Children's Hospital, Seattle, Washington, United States
Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: Elliot Stieglitz
Affiliation: Children's Oncology Group
Role: PRINCIPAL_INVESTIGATOR
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