Spots Global Cancer Trial Database for Glembatumumab Vedotin in Treating Patients With Recurrent or Refractory Osteosarcoma
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: Glembatumumab Vedotin in Treating Patients With Recurrent or Refractory Osteosarcoma
Official Title: A Phase 2 Study of GPNMB-Targeted Antibody-Drug Conjugate, CDX-011 (Glembatumumab Vedotin, CR011-vcMMAE; NSC# 763737), in Recurrent or Refractory Osteosarcoma
Study ID: NCT02487979
Conditions
Study Description
Brief Summary: This phase II trial studies how well glembatumumab vedotin works in treating patients with osteosarcoma that has come back (recurrent) or does not respond to treatment (refractory). Monoclonal antibodies, such as glembatumumab vedotin, may find tumor cells and help kill them.
Detailed Description: PRIMARY OBJECTIVES: I. To estimate whether CDX-011 (glembatumumab vedotin) therapy either increases the disease control rate at 4 months in patients with recurrent measurable osteosarcoma as compared to an historical Children's Oncology Group (COG) experience or produces an objective response rate in patients without previous eribulin (eribulin mesylate) treatment. SECONDARY OBJECTIVES: I. To assess the feasibility and toxicity profile of CDX-011 in patients with recurrent osteosarcoma. II. To describe the pharmacokinetics of CDX-011 in adolescents and young adults with recurrent osteosarcoma enrolled at COG sites and COG phase I consortium sites only. III. To determine if there is a relationship between tumor GPNMB expression by immunohistochemistry (IHC) and response to CDX-011 therapy. IV. To estimate, in the cohort of patients previously treated with eribulin, the proportion who will experience disease progression during the first 4 months of CDX-011 therapy and the proportion of patients who experience a Response Evaluation Criteria in Solid Tumors (RECIST)-defined complete or partial response. OUTLINE: Patients receive glembatumumab vedotin intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically.
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
Banner University Medical Center - Tucson, Tucson, Arizona, United States
University of Arizona Cancer Center-North Campus, Tucson, Arizona, United States
Arkansas Children's Hospital, Little Rock, Arkansas, United States
Kaiser Permanente-Anaheim, Anaheim, California, United States
PCR Oncology, Arroyo Grande, California, United States
Kaiser Permanente-Bellflower, Bellflower, California, United States
Kaiser Permanente Downey Medical Center, Downey, California, United States
Kaiser Permanente-Fontana, Fontana, California, United States
Loma Linda University Medical Center, Loma Linda, California, United States
Children's Hospital Los Angeles, Los Angeles, California, United States
Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States
Mattel Children's Hospital UCLA, Los Angeles, California, United States
Valley Children's Hospital, Madera, 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
Kaiser Permanente-San Diego Zion, San Diego, California, United States
Rady Children's Hospital - San Diego, San Diego, California, United States
UCSF Medical Center-Mission Bay, San Francisco, California, United States
Children's Hospital Colorado, Aurora, Colorado, United States
University of Colorado Hospital, 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
Smilow Cancer Center/Yale-New Haven Hospital, New Haven, Connecticut, United States
Yale University, New Haven, Connecticut, United States
Alfred I duPont Hospital for Children, Wilmington, Delaware, United States
Kaiser Permanente-Capitol Hill Medical Center, Washington, District of Columbia, United States
Children's National Medical Center, Washington, District of Columbia, United States
Sibley Memorial Hospital, Washington, District of Columbia, United States
Golisano Children's Hospital of Southwest Florida, Fort Myers, Florida, United States
University of Florida Health Science Center - Gainesville, Gainesville, Florida, United States
Nemours Children's Clinic-Jacksonville, Jacksonville, Florida, United States
Nicklaus Children's Hospital, Miami, Florida, United States
AdventHealth Orlando, Orlando, Florida, United States
Nemours Children's Hospital, Orlando, Florida, United States
Nemours Children's Clinic - Pensacola, Pensacola, Florida, United States
Johns Hopkins All Children's Hospital, Saint Petersburg, Florida, United States
Tampa General Hospital, Tampa, 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
Saint Luke's Cancer Institute - Boise, Boise, Idaho, United States
Rush - Copley Medical Center, Aurora, Illinois, United States
Lurie Children's Hospital-Chicago, Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Carle on Vermilion, Danville, Illinois, United States
Carle Physician Group-Effingham, Effingham, Illinois, United States
Carle Physician Group-Mattoon/Charleston, Mattoon, Illinois, United States
Saint Jude Midwest Affiliate, Peoria, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
The Carle Foundation Hospital, Urbana, Illinois, United States
Rush-Copley Healthcare Center, Yorkville, Illinois, United States
IU Health North Hospital, Carmel, Indiana, United States
Riley Hospital for Children, Indianapolis, Indiana, United States
Memorial Hospital of South Bend, South Bend, 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
Ochsner Medical Center Jefferson, New Orleans, Louisiana, 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
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States
Ascension Saint John Hospital, Detroit, Michigan, United States
Lake Huron Medical Center, Port Huron, Michigan, United States
University of Minnesota/Masonic Cancer Center, Minneapolis, Minnesota, United States
Mayo Clinic in Rochester, Rochester, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Saint Louis Cancer and Breast Institute-Ballwin, Ballwin, Missouri, United States
Children's Mercy Hospitals and Clinics, Kansas City, Missouri, United States
Delbert Day Cancer Institute at PCRMC, 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
Mercy Hospital Washington, Washington, Missouri, United States
Carson Tahoe Regional Medical Center, Carson City, Nevada, 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
Radiation Oncology Centers of Nevada Central, Las Vegas, Nevada, United States
21st Century Oncology, 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
21st Century Oncology-Vegas Tenaya, Las Vegas, Nevada, United States
Ann M Wierman MD LTD, 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
Alliance for Childhood Diseases/Cure 4 the Kids Foundation, 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
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
OptumCare Cancer Care at Fort Apache, 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
Renown Regional Medical Center, Reno, Nevada, United States
Saint Mary's Regional Medical Center, Reno, Nevada, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Albany Medical Center, Albany, New York, United States
Montefiore Medical Center-Einstein Campus, Bronx, New York, United States
Montefiore Medical Center-Weiler Hospital, Bronx, New York, United States
Children's Hospital at Montefiore, Bronx, New York, United States
Montefiore Medical Center - Moses Campus, Bronx, New York, United States
NYU Winthrop Hospital, Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York, New York, United States
State University of New York Upstate Medical University, Syracuse, New York, United States
Children's Hospital Medical Center of Akron, Akron, Ohio, 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
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital, Toledo, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Children's Oncology Group, Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States
Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, United States
Vanderbilt-Ingram Cancer Center Cool Springs, Franklin, Tennessee, United States
East Tennessee Childrens Hospital, Knoxville, Tennessee, United States
Saint Jude Children's Research Hospital, Memphis, Tennessee, United States
Vanderbilt Breast Center at One Hundred Oaks, 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
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
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio, San Antonio, Texas, United States
Methodist Children's Hospital of South Texas, San Antonio, Texas, United States
University Hospital, San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Children's Hospital of The King's Daughters, Norfolk, Virginia, United States
Seattle Children's Hospital, Seattle, Washington, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
University of Washington Medical Center - Montlake, Seattle, Washington, United States
Providence Sacred Heart Medical Center and Children's Hospital, Spokane, Washington, United States
Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States
Alberta Children's Hospital, Calgary, Alberta, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
IWK Health Centre, Halifax, Nova Scotia, Canada
The Montreal Children's Hospital of the MUHC, Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec, Quebec, , Canada
University Pediatric Hospital, San Juan, , Puerto Rico
Contact Details
Name: Lisa M Kopp
Affiliation: Children's Oncology Group
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:
