Spots Global Cancer Trial Database for Osteosarcoma Maintenance Therapy With OST31-164
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Trial Identification
Brief Title: Osteosarcoma Maintenance Therapy With OST31-164
Official Title: An Open-Label Phase 2 Study of Maintenance Therapy With OST31-164 After Resection of Recurrent Osteosarcoma
Study ID: NCT04974008
Conditions
Interventions
Study Description
Brief Summary: Up to 45 Patients aged 12 to 39 with osteosarcoma (bone cancer) that had recurred in the lungs and has recently been surgically removed will be enrolled. Patients will receive OST31-164 infusions every 3 weeks over 48 weeks and be followed after that for 3 years.
Detailed Description: This is a Phase 2, open-label, multicenter, single-arm study in patients (12-39 years) with a recent history of pulmonary recurrent osteosarcoma that has been completely resected. Planned enrollment is a maximum of 45 patients who will receive OST31-164 as a single agent every 3 weeks for 48 weeks with 4 doses constituting 1 treatment cycle (12 weeks per cycle). Each patient will receive treatment at a dose of 1x109 CFU until week 48 or until disease progression, unacceptable toxicity, or the patient meets any other treatment discontinuation criteria. Following treatment discontinuation, all patients will enter a 3-year survival follow-up period. Exploratory evaluation of immune response will be conducted. If available, tissue from the recent resection will be sent to the COG Biobank for future genomic and pathologic analysis by the COG.
Keywords
Eligibility
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Kaiser Permanente Downey Medical Center, Los Angeles, California, United States
Children's Hospital of Orange County, Orange, California, United States
Rady Children's Hospital, San Diego, California, United States
Children's Hospital of Colorado, Aurora, Colorado, United States
Connecticut Children's, Hartford, Connecticut, United States
Nemours/ Alfred I duPont Hospital for Children, Wilmington, Delaware, United States
Johns Hopkins All Children's Hospital, Saint Petersburg, Florida, United States
Children's Healthcare of Atlanta, Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States
Johns Hopkins Medical Center, Baltimore, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Minnesota/Masonic Cancer Center, Minneapolis, Minnesota, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Montefiore Medical Center, Bronx, New York, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
Oregon Health & Science University, Portland, Oregon, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
UT Southwestern Medical Center, Dallas, Texas, United States
Seattle Children's Hospital, Seattle, Washington, United States
Contact Details
Name: Robert Petit, PhD
Affiliation: OS Therapies, Inc.
Role: STUDY_DIRECTOR
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