Spots Global Cancer Trial Database for Eribulin Mesylate in Treating Patients With Recurrent or Refractory Osteosarcoma
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Trial Identification
Brief Title: Eribulin Mesylate in Treating Patients With Recurrent or Refractory Osteosarcoma
Official Title: A Phase II Study of Eribulin (NSC# 707389) in Recurrent or Refractory Osteosarcoma
Study ID: NCT02097238
Conditions
Study Description
Brief Summary: This phase II trial studies how well eribulin mesylate works in treating patients with osteosarcoma that has come back after treatment (recurrent) or has not responded to treatment (refractory). Microtubule inhibitors, such as eribulin mesylate, may stop or slow the growth of tumor cells by disrupting the cell cycle.
Detailed Description: PRIMARY OBJECTIVES: I. To estimate the 4 month progression free survival rate and objective response rate in patients with recurrent osteosarcoma who are administered eribulin (eribulin mesylate) therapy on day 1 and day 8 of 21 day cycles. SECONDARY OBJECTIVES: I. To investigate the pharmacokinetics (PK) of eribulin in subjects with recurrent osteosarcoma. II. To further describe the tolerability of single agent eribulin. OUTLINE: Patients receive eribulin mesylate intravenously (IV) over 2-5 minutes on days 1 and 8. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up annually for 5 years.
Keywords
Eligibility
Minimum Age: 12 Years
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
Southern California Permanente Medical Group, Downey, California, United States
Loma Linda University Medical Center, Loma Linda, California, United States
Children's Hospital Los Angeles, Los Angeles, California, United States
Mattel Children's Hospital UCLA, Los Angeles, California, United States
Children's Hospital Central California, Madera, California, United States
Children's Hospital and Research Center at 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
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
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
Nemours Children's Hospital, Orlando, Florida, United States
Nemours Children's Clinic - Pensacola, Pensacola, Florida, United States
All Children's Hospital, Saint Petersburg, Florida, United States
Saint Joseph's Hospital/Children's Hospital-Tampa, Tampa, Florida, United States
Saint Mary's Hospital, West Palm Beach, Florida, United States
Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia, United States
Memorial University Medical Center, Savannah, Georgia, United States
Lurie Children's Hospital-Chicago, Chicago, Illinois, United States
University of Illinois, Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Good Samaritan Regional Health Center, Mount Vernon, Illinois, United States
Advocate Children's Hospital-Oak Lawn, Oak Lawn, Illinois, United States
Saint Jude Midwest Affiliate, Peoria, Illinois, United States
Riley Hospital for Children, Indianapolis, Indiana, United States
Saint Vincent Hospital and Health Care Center, Indianapolis, Indiana, United States
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
Siouxland Regional Cancer Center, Sioux City, Iowa, United States
University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States
Ochsner Medical Center Jefferson, New Orleans, Louisiana, United States
Maine Children's Cancer Program, Scarborough, Maine, United States
Sinai Hospital of Baltimore, Baltimore, Maryland, United States
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States
Michigan State University Clinical Center, East Lansing, Michigan, United States
Essentia Health Cancer Center, Duluth, Minnesota, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis, Minneapolis, Minnesota, United States
University of Minnesota Medical Center-Fairview, Minneapolis, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Central Care Cancer Center-Carrie J Babb Cancer Center, Bolivar, Missouri, United States
CoxHealth Cancer Center, Branson, Missouri, United States
Freeman Health System, Joplin, Missouri, United States
Mercy Hospital-Joplin, Joplin, Missouri, United States
The Childrens Mercy Hospital, Kansas City, Missouri, United States
Phelps County Regional Medical Center, Rolla, Missouri, United States
Saint John's Clinic-Rolla-Cancer and Hematology, Rolla, Missouri, United States
Saint Louis Cancer and Breast Institute-South City, Saint Louis, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Mercy Hospital Saint Louis, Saint Louis, Missouri, United States
Mercy Hospital Springfield, Springfield, Missouri, United States
CoxHealth South Hospital, Springfield, Missouri, United States
Children's Hospital and Medical Center of Omaha, Omaha, Nebraska, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Cancer and Blood Specialists-Henderson, Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada - Henderson, Henderson, Nevada, United States
Las Vegas Cancer Center-Henderson, Henderson, Nevada, United States
21st Century Oncology - Henderson, Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada-Southeast Henderson, Henderson, Nevada, United States
Cancer and Blood Specialists-Shadow, Las Vegas, Nevada, United States
Nevada Cancer Research Foundation CCOP, Las Vegas, Nevada, United States
Radiation Oncology Centers of Nevada Central, Las Vegas, Nevada, United States
21st Century Oncology, Las Vegas, Nevada, United States
Children's Specialty Center of Nevada II, Las Vegas, Nevada, United States
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway, Las Vegas, Nevada, United States
HealthCare Partners Medical Group Oncology/Hematology-San Martin, Las Vegas, Nevada, United States
Radiation Oncology Centers of Nevada Southeast, Las Vegas, Nevada, United States
Cancer Therapy and Integrative Medicine, Las Vegas, Nevada, United States
Cancer and Blood Specialists-Tenaya, Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Northwest, Las Vegas, Nevada, United States
HealthCare Partners Medical Group Oncology/Hematology-Tenaya, Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada-Summerlin, Las Vegas, Nevada, United States
Summerlin Hospital Medical Center, Las Vegas, Nevada, United States
Las Vegas Cancer Center-Medical Center, Las Vegas, Nevada, United States
21st Century Oncology - Fort Apache, Las Vegas, Nevada, United States
Cancer and Blood Specialists-Fort Apache, Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills, Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Central Valley, Las Vegas, Nevada, United States
21st Century Oncology - Vegas Tenaya, Las Vegas, Nevada, United States
Montefiore Medical Center - Moses Campus, Bronx, New York, United States
The Steven and Alexandra Cohen Children's Medical Center of New York, New Hyde Park, New York, United States
Columbia University Medical Center, New York, New York, United States
State University of New York Upstate Medical University, Syracuse, New York, United States
Mission Hospital-Memorial Campus, Asheville, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Sanford Medical Center-Fargo, Fargo, North Dakota, United States
Children's Hospital Medical Center of Akron, Akron, Ohio, 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
The Toledo Hospital/Toledo Children's Hospital, Toledo, Ohio, United States
Legacy Emanuel Children's Hospital, Portland, Oregon, United States
Oregon Health and Science University, Portland, Oregon, United States
Lehigh Valley Hospital - Muhlenberg, Bethlehem, Pennsylvania, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States
Palmetto Health Richland, Columbia, South Carolina, United States
Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, United States
East Tennessee Childrens Hospital, Knoxville, Tennessee, United States
St. Jude Children's Research Hospital, Memphis, Tennessee, 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, Houston, Texas, United States
Children's Hospital of San Antonio, San Antonio, Texas, United States
Childrens Hospital-King's Daughters, Norfolk, Virginia, United States
Seattle Children's Hospital, Seattle, Washington, United States
Providence Sacred Heart Medical Center and Children's Hospital, Spokane, Washington, United States
West Virginia University Healthcare, Morgantown, West Virginia, United States
British Columbia Children's Hospital, Vancouver, British Columbia, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada
Contact Details
Name: Michael Isakoff
Affiliation: Children's Oncology Group
Role: PRINCIPAL_INVESTIGATOR
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