Spots Global Cancer Trial Database for Palbociclib in Treating Patients With Relapsed or Refractory Rb Positive Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating Alterations in Cell Cycle Genes (A Pediatric MATCH Treatment Trial)
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Trial Identification
Brief Title: Palbociclib in Treating Patients With Relapsed or Refractory Rb Positive Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating Alterations in Cell Cycle Genes (A Pediatric MATCH Treatment Trial)
Official Title: NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of Palbociclib in Patients With Tumors Harboring Activating Alterations in Cell Cycle Genes
Study ID: NCT03526250
Conditions
Study Description
Brief Summary: This phase II Pediatric MATCH trial studies how well palbociclib works in treating patients with Rb positive solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with activating alterations (mutations) in cell cycle genes that have spread to other places in the body and have come back or do not respond to treatment. Palbociclib may stop the growth of cancer cells by blocking some of the proteins needed for cell growth.
Detailed Description: PRIMARY OBJECTIVE: I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with palbociclib with advanced solid tumors (including central nervous system \[CNS\] tumors), non-Hodgkin lymphomas or histiocytic disorders that harbor activating genetic alterations in cell cycle genes. SECONDARY OBJECTIVES: I. To estimate the progression free survival in pediatric patients treated with palbociclib with advanced solid tumors (including CNS tumors), non-Hodgkin lymphomas or histiocytic disorders that harbor activating genetic alterations in alterations in cell cycle genes. II. To obtain information about the tolerability of palbociclib in children and adolescents with relapsed or refractory cancer. EXPLORATORY OBJECTIVE: I. To explore approaches to profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid (DNA). OUTLINE: Patients receive palbociclib orally (PO) once daily (QD) on days 1-21. Cycles repeat every 28 days for up to 2 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
Providence Alaska Medical Center, Anchorage, Alaska, United States
Banner Children's at Desert, Mesa, Arizona, United States
Phoenix Childrens Hospital, Phoenix, Arizona, United States
Banner University Medical Center - Tucson, Tucson, Arizona, United States
Arkansas Children's Hospital, Little Rock, Arkansas, United States
Kaiser Permanente Downey Medical Center, Downey, California, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
Loma Linda University Medical Center, Loma Linda, California, United States
Miller Children's and Women's Hospital Long Beach, Long Beach, California, United States
Children's Hospital Los Angeles, Los Angeles, California, United States
Mattel Children's Hospital UCLA, Los Angeles, California, United States
Valley Children's Hospital, Madera, California, United States
UCSF Benioff Children's Hospital Oakland, Oakland, 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
University of California Davis Comprehensive Cancer Center, Sacramento, 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
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
Broward Health Medical Center, Fort Lauderdale, Florida, United States
University of Florida Health Science Center - Gainesville, Gainesville, Florida, 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
AdventHealth Orlando, Orlando, Florida, United States
Arnold Palmer Hospital for Children, Orlando, Florida, United States
Nemours Children's Hospital, Orlando, Florida, United States
Johns Hopkins All Children's Hospital, Saint Petersburg, 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
Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, United States
Saint Luke's Cancer Institute - Boise, Boise, Idaho, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Saint Jude Midwest Affiliate, Peoria, Illinois, United States
Southern Illinois University School of Medicine, Springfield, Illinois, United States
Riley Hospital for Children, Indianapolis, Indiana, United States
Blank Children's Hospital, Des Moines, Iowa, United States
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States
Children's Hospital New Orleans, New Orleans, Louisiana, United States
Ochsner Medical Center Jefferson, New Orleans, Louisiana, United States
Eastern Maine Medical Center, Bangor, Maine, United States
Sinai Hospital of Baltimore, Baltimore, Maryland, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
C S Mott Children's Hospital, Ann Arbor, Michigan, United States
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital, Grand Rapids, Michigan, United States
Bronson Methodist Hospital, Kalamazoo, 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
University of Mississippi Medical Center, Jackson, Mississippi, United States
Children's Mercy Hospitals and Clinics, Kansas City, Missouri, United States
Cardinal Glennon Children's Medical Center, Saint Louis, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Mercy Hospital Saint Louis, Saint Louis, Missouri, United States
Children's Hospital and Medical Center of Omaha, Omaha, Nebraska, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Morristown Medical Center, Morristown, New Jersey, United States
Saint Peter's University Hospital, New Brunswick, New Jersey, United States
Albany Medical Center, Albany, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
The Steven and Alexandra Cohen Children's Medical Center of New York, New Hyde Park, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
NYP/Weill Cornell Medical Center, New York, New York, United States
University of Rochester, Rochester, New York, United States
State University of New York Upstate Medical University, Syracuse, New York, United States
Mission Hospital, Asheville, North Carolina, United States
Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Sanford Broadway Medical Center, Fargo, North Dakota, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Rainbow Babies and Childrens Hospital, Cleveland, Ohio, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
Dayton Children's Hospital, Dayton, Ohio, United States
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital, Toledo, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Legacy Emanuel Children's Hospital, Portland, Oregon, United States
Oregon Health and Science University, Portland, Oregon, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States
Prisma Health Richland Hospital, Columbia, South Carolina, United States
BI-LO Charities Children's Cancer Center, Greenville, South Carolina, United States
Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, United States
East Tennessee Childrens Hospital, Knoxville, Tennessee, United States
Saint Jude Children's Research Hospital, Memphis, Tennessee, United States
Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States
Dell Children's Medical Center of Central Texas, Austin, Texas, United States
Driscoll Children's Hospital, Corpus Christi, Texas, United States
Medical City Dallas Hospital, Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States
Cook Children's Medical Center, Fort Worth, Texas, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston, Texas, United States
M D Anderson Cancer Center, Houston, Texas, United States
Covenant Children's Hospital, Lubbock, Texas, United States
Children's Hospital of San Antonio, San Antonio, Texas, United States
Methodist Children's Hospital of South Texas, San Antonio, Texas, United States
Scott and White Memorial Hospital, Temple, Texas, United States
Primary Children's Hospital, Salt Lake City, Utah, United States
University of Vermont and State Agricultural College, Burlington, Vermont, United States
Children's Hospital of The King's Daughters, Norfolk, Virginia, United States
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States
Seattle Children's Hospital, Seattle, Washington, United States
Providence Sacred Heart Medical Center and Children's Hospital, Spokane, Washington, United States
Madigan Army Medical Center, Tacoma, Washington, United States
University of Wisconsin Carbone Cancer Center - University Hospital, Madison, Wisconsin, United States
Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States
San Jorge Children's Hospital, San Juan, , Puerto Rico
University Pediatric Hospital, San Juan, , Puerto Rico
Contact Details
Name: Rajen Mody
Affiliation: Children's Oncology Group
Role: PRINCIPAL_INVESTIGATOR
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