Spots Global Cancer Trial Database for Dinutuximab in Combination With Sargramostim in Treating Patients With Recurrent Osteosarcoma
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Trial Identification
Brief Title: Dinutuximab in Combination With Sargramostim in Treating Patients With Recurrent Osteosarcoma
Official Title: A Phase 2 Study of Human-Mouse Chimeric Anti-disialoganglioside Monoclonal Antibody ch14.18 (Dinutuximab, NSC# 764038) in Combination With Sargramostim (GM-CSF) in Patients With Recurrent Osteosarcoma
Study ID: NCT02484443
Study Description
Brief Summary: This phase II trial studies how well dinutuximab works when given with sargramostim in treating patients with osteosarcoma that has come back after treatment (recurrent). Monoclonal antibodies, such as dinutuximab, may find tumor cells and help kill them. Sargramostim may help the body increase the amount of white blood cells it produces, which help the body fight off infections. Giving dinutuximab with sargramostim may work better and kill more cancer cells.
Detailed Description: PRIMARY OBJECTIVES: I. To determine the disease control rate in patients with completely resected recurrent osteosarcoma treated with ch14.18 (dinutuximab) in combination with sargramostim (granulocyte-macrophage colony-stimulating factor \[GM-CSF\]) as compared to historical Children's Oncology Group (COG) experience. SECONDARY OBJECTIVES: I. To characterize the pharmacokinetics of ch14.18 (dinutuximab) in patients with recurrent osteosarcoma. II. To determine the occurrence of unacceptable toxicity (UT) in patients with recurrent osteosarcoma treated with ch14.18 (dinutuximab) in combination with sargramostim. III. To assess the relationship between probability of disease control and tumor ganglioside GD2 (GD2) expression. TERTIARY OBJECTIVES: I. To assess the relationship between probability of disease control and tumor GD2 expression. II. To assess KIR and Fcgamma receptor (FcgammaR) genotypes, NKp30 isoforms and its circulating ligand, B7-H6, and their relationships to the probability of disease control. III. To attempt banking of tumor samples for future research studies from patients enrolled on study who undergo biopsy or resection of suspected metastatic disease recurrence while on protocol therapy or during the evaluation period. IV. To determine a descriptive profile of human anti-chimeric antibody (HACA) during immunotherapy. V. To bank serial plasma samples for future studies of circulating tumor deoxyribonucleic acid (ctDNA) detection as a marker of disease progression and response. OUTLINE: Patients receive sargramostim subcutaneously (SC) once daily (QD) on days 1-14 and dinutuximab intravenously (IV) over 10 hours on days 4-7 (dinutuximab infusion may be extended up to a total of 20 hours per day for anticipated toxicities). Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 8 and 12 months.
Keywords
Eligibility
Minimum Age:
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
Children's Hospital Los Angeles, 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
Connecticut Children's Medical Center, Hartford, Connecticut, United States
Yale University, New Haven, Connecticut, United States
Alfred I duPont Hospital for Children, Wilmington, Delaware, United States
Children's National Medical Center, Washington, District of Columbia, 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
Arnold Palmer Hospital for Children, 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
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 Health University Medical Center, Savannah, Georgia, United States
Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, United States
Saint Luke's Cancer Institute - Boise, Boise, Idaho, 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
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
Ascension Saint Vincent Indianapolis Hospital, 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
Norton Children's Hospital, Louisville, Kentucky, 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
Ascension Saint John Hospital, Detroit, Michigan, United States
Helen DeVos Children's Hospital at Spectrum Health, Grand Rapids, Michigan, United States
Bronson Methodist Hospital, Kalamazoo, Michigan, United States
Beaumont Children's Hospital-Royal Oak, Royal Oak, 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
Mayo Clinic in Rochester, Rochester, 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
University Medical Center of Southern Nevada, Las Vegas, Nevada, United States
Sunrise Hospital and Medical Center, Las Vegas, Nevada, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation, Las Vegas, Nevada, United States
Summerlin Hospital Medical Center, Las Vegas, Nevada, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer 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 - Moses Campus, Bronx, 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
University of Rochester, Rochester, New York, United States
State University of New York Upstate Medical University, Syracuse, New York, United States
New York Medical College, Valhalla, New York, 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
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
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
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
Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, United States
Saint Jude Children's Research Hospital, Memphis, Tennessee, United States
The Children's Hospital at TriStar Centennial, 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
Covenant Children's Hospital, Lubbock, Texas, United States
Children's Hospital of San Antonio, San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, 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
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
West Virginia University Healthcare, Morgantown, West Virginia, United States
Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States
John Hunter Children's Hospital, Hunter Regional Mail Centre, New South Wales, Australia
Sydney Children's Hospital, Randwick, New South Wales, Australia
The Children's Hospital at Westmead, Westmead, New South Wales, Australia
Queensland Children's Hospital, South Brisbane, Queensland, Australia
Women's and Children's Hospital-Adelaide, North Adelaide, South Australia, Australia
Monash Medical Center-Clayton Campus, Clayton, Victoria, Australia
Royal Children's Hospital, Parkville, Victoria, Australia
Princess Margaret Hospital for Children, Perth, Western Australia, Australia
Alberta Children's Hospital, Calgary, Alberta, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
IWK Health Centre, Halifax, Nova Scotia, Canada
Children's Hospital, London, Ontario, Canada
Hospital for Sick Children, Toronto, Ontario, Canada
The Montreal Children's Hospital of the MUHC, Montreal, Quebec, Canada
Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL), Quebec, , Canada
Starship Children's Hospital, Grafton, Auckland, New Zealand
Christchurch Hospital, Christchurch, , New Zealand
University Pediatric Hospital, San Juan, , Puerto Rico
Contact Details
Name: Pooja Hingorani
Affiliation: Children's Oncology Group
Role: PRINCIPAL_INVESTIGATOR
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