Smart Patients is an online community for patients and their families. Join us to talk with other patients about the latest research for your condition.

Overview

Status Active not recruiting
Phase Phase 2
Sponsor Children's Oncology Group
Start date November 2015
End date December 2019
Enrollment 56 participants
Identifiers NCT02470091, AOST1321, NCI-2015-00543, s15-01360, AOST1321, AOST1321, AOST1321, U10CA180886

Conditions

Metastatic Osteosarcoma, Recurrent Osteosarcoma, Refractory Osteosarcoma, Stage IV Osteosarcoma AJCC v7, Stage IVA Osteosarcoma AJCC v7, Stage IVB Osteosarcoma AJCC v7

Treatments

Denosumab, Laboratory Biomarker Analysis, Pharmacological Study

Summary

This phase II trial studies how well denosumab works in treating patients with osteosarcoma that has come back (recurrent) or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as denosumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Locations

Children's Hospital of Alabama
Birmingham, Alabama
Phoenix Childrens Hospital
Phoenix, Arizona
Banner University Medical Center - Tucson
Tucson, Arizona
Arkansas Children's Hospital
Little Rock, Arkansas
Kaiser Permanente-Anaheim
Anaheim, California
Kaiser Permanente-Bellflower
Bellflower, California
Kaiser Permanente Downey Medical Center
Downey, California
Kaiser Permanente-Fontana
Fontana, California
Loma Linda University Medical Center
Loma Linda, California
Children's Hospital Los Angeles
Los Angeles, California
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California
Valley Children's Hospital
Madera, California
Children's Hospital and Research Center at Oakland
Oakland, California
Children's Hospital of Orange County
Orange, California
University of California Davis Comprehensive Cancer Center
Sacramento, California
Kaiser Permanente-San Diego Zion
San Diego, California
Rady Children's Hospital - San Diego
San Diego, California
UCSF Medical Center-Mission Bay
San Francisco, California
Children's Hospital Colorado
Aurora, Colorado
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado
Connecticut Children's Medical Center
Hartford, Connecticut
Alfred I duPont Hospital for Children
Wilmington, Delaware
Children's National Medical Center
Washington, District of Columbia
University of Florida Health Science Center - Gainesville
Gainesville, Florida
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida
Nicklaus Children's Hospital
Miami, Florida
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida
AdventHealth Orlando
Orlando, Florida
Nemours Children's Hospital
Orlando, Florida
Johns Hopkins All Children's Hospital
Saint Petersburg, Florida
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida
Saint Mary's Hospital
West Palm Beach, Florida
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii
Saint Luke's Mountain States Tumor Institute
Boise, Idaho
Centralia Oncology Clinic
Centralia, Illinois
Lurie Children's Hospital-Chicago
Chicago, Illinois
University of Chicago Comprehensive Cancer Center
Chicago, Illinois
University of Illinois
Chicago, Illinois
Carle on Vermilion
Danville, Illinois
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois
Carle Physician Group-Effingham
Effingham, Illinois
Crossroads Cancer Center
Effingham, Illinois
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois
Cancer Care Center of O'Fallon
O'Fallon, Illinois
Saint Jude Midwest Affiliate
Peoria, Illinois
Carle Cancer Center
Urbana, Illinois
The Carle Foundation Hospital
Urbana, Illinois
Riley Hospital for Children
Indianapolis, Indiana
Saint Vincent Hospital and Health Care Center
Indianapolis, Indiana
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa
University of Kentucky/Markey Cancer Center
Lexington, Kentucky
Norton Children's Hospital
Louisville, Kentucky
Ochsner Medical Center Jefferson
New Orleans, Louisiana
Maine Children's Cancer Program
Scarborough, Maine
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland
Sinai Hospital of Baltimore
Baltimore, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland
Brigham and Women's Hospital
Boston, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts
UMass Memorial Medical Center - University Campus
Worcester, Massachusetts
C S Mott Children's Hospital
Ann Arbor, Michigan
Ascension Saint John Hospital
Detroit, Michigan
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan
Bronson Methodist Hospital
Kalamazoo, Michigan
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota
University of Mississippi Medical Center
Jackson, Mississippi
Children's Mercy Hospitals and Clinics
Kansas City, Missouri
Mercy Hospital Saint Louis
Saint Louis, Missouri
Washington University School of Medicine
Saint Louis, Missouri
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada
Sunrise Hospital and Medical Center
Las Vegas, Nevada
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire
Hackensack University Medical Center
Hackensack, New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey
Newark Beth Israel Medical Center
Newark, New Jersey
University of New Mexico Cancer Center
Albuquerque, New Mexico
Albany Medical Center
Albany, New York
Roswell Park Cancer Institute
Buffalo, New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York
Memorial Sloan Kettering Cancer Center
New York, New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York
University of Rochester
Rochester, New York
State University of New York Upstate Medical University
Syracuse, New York
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina
Sanford Broadway Medical Center
Fargo, North Dakota
Children's Hospital Medical Center of Akron
Akron, Ohio
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio
Case Western Reserve University
Cleveland, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio
Rainbow Babies and Childrens Hospital
Cleveland, Ohio
Nationwide Children's Hospital
Columbus, Ohio
Dayton Children's Hospital
Dayton, Ohio
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma
Oregon Health and Science University
Portland, Oregon
Penn State Children's Hospital
Hershey, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania
Children's Oncology Group
Philadelphia, Pennsylvania
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania
Rhode Island Hospital
Providence, Rhode Island
Medical University of South Carolina
Charleston, South Carolina
Prisma Health Richland Hospital
Columbia, South Carolina
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota
Saint Jude Children's Research Hospital
Memphis, Tennessee
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee
Dell Children's Medical Center of Central Texas
Austin, Texas
Driscoll Children's Hospital
Corpus Christi, Texas
Medical City Dallas Hospital
Dallas, Texas
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas
Cook Children's Medical Center
Fort Worth, Texas
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas
Children's Hospital of San Antonio
San Antonio, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas
Primary Children's Hospital
Salt Lake City, Utah
University of Vermont and State Agricultural College
Burlington, Vermont
University of Virginia Cancer Center
Charlottesville, Virginia
Children's Hospital of The King's Daughters
Norfolk, Virginia
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia
Seattle Children's Hospital
Seattle, Washington
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington
West Virginia University Healthcare
Morgantown, West Virginia
Children's Hospital of Wisconsin
Milwaukee, Wisconsin
Centre Hospitalier Universitaire de Quebec
Quebec, Canada
University of Alberta Hospital
Edmonton, Canada
IWK Health Centre
Halifax, Canada
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Canada
Children's Hospital
London, Canada
Hospital for Sick Children
Toronto, Canada
The Montreal Children's Hospital of the MUHC
Montreal, Canada
San Jorge Children's Hospital
San Juan, Puerto Rico
University Pediatric Hospital
San Juan, Puerto Rico

Inclusion Criteria

» Female patients must have a bone age of equal to or greater than 12 years of age as determined by local read of appropriate radiographic imaging
» Male patients must have a bone age of equal to or greater than 14 years of age as determined by local read of appropriate radiographic imaging
» Patients must have relapsed or become refractory to conventional therapy, with a regimen including some combination of high dose methotrexate, doxorubicin, cisplatin, ifosfamide and etoposide; and have had histologic verification of osteosarcoma at original diagnosis or at the time of recurrence
» Cohort 1 patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
» Cohort 2 patients must have had a complete resection of all sites of metastatic disease within 30 days prior to enrollment
» Patients will only be eligible after they have undergone complete surgical resection of suspected metastatic disease that is histopathologically confirmed to be osteosarcoma prior to enrollment
» Note: the definition of complete resections is: gross resection of all disease as per the operating surgeon; post-operative imaging is not required for confirmation of complete resection
» Patients must undergo resection of any lung lesion meeting criteria for likely metastatic disease, defined as:
» 3 or more lesions > 5 mm in diameter OR a single lesion > 1 cm
» Patients with lung as the only site of resected metastatic disease must have refused participation in protocol AOST1421
» Note: This applies if AOST1421 is open to enrollment at the enrolling institution on the day the patient consents
» Patient must have adequate tumor specimen available for submission
» Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
» Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:
» Age: 11 to < 13 years old; 1.2 (male, female) maximum serum creatinine (mg/dL)
» Age: 13 to < 16 years old; 1.5 (male), 1.4 (female) maximum serum creatinine (mg/dL)
» Age: >= 16 years old; 1.7 (male), 1.4 (female) maximum serum creatinine (mg/dL)
» Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
» Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x ULN for age
» Serum calcium or albumin-adjusted serum calcium >= 2.0 mmol/L (8.0 mg/dL) and =< 2.9 mmol/L (11.5 mg/dL)

Exclusion Criteria

» Patients with known sensitivity to any of the products to be administered during the study (eg, mammalian derived products, calcium or vitamin D)
» Patients who are receiving other cancer directed therapy at the time of enrollment
» Patients who have previously received denosumab
» Patients who have previously received mithramycin, strontium-89, samarium-153 or rhenium
» Patients receiving bisphosphonates
» Pre-existing conditions
» Disorders associated with abnormal bone metabolism
» Hypocalcemia that is not corrected with oral calcium supplementation
» Vitamin D < 20 mg/mL
» Paget's disease
» Prior history or current evidence of osteonecrosis of the jaw
» Any dental or oral condition likely to result in disruption of mucosal integrity during denosumab therapy including: active dental or jaw condition requiring oral surgery or tooth extraction; non-healed dental or oral surgery or planned invasive dental procedures during the anticipated course of study therapy
» Unstable systemic disease, excluding osteosarcoma, such as unstable proximal renal tubule dysfunction (Fanconi syndrome) or congestive heart failure
» Pregnancy and breast feeding
» Female patients who are pregnant; a pregnancy test is required for female patients of childbearing potential
» Lactating females who plan to breastfeed their infants while on study therapy and through 5 months after completion of study therapy
» Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation and for 5 months after the end of study treatment
» All patients and/or their parents or legal guardians must sign a written informed consent
» All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met