Condition: Pediatric Sarcoma, Refractory · Pediatric Sarcoma, Relapsed · Sponsor: Nationwide Children's Hospital
The purpose of this study is to determine if the addition of infusions of a type of immune cell called a "natural killer", or NK cell to the sarcoma chemotherapy regimen GEM/DOX (gemcitabine and docetaxel) can improve outcomes in people with childhood sarcomas that have relapsed or not responded to prior therapies. The goals of this study are: * To determine the safety and efficacy of the addition of adoptive transfer of universal donor, TGFβ imprinted (TGFβi), expanded NK cells to the pediatric sarcoma salvage chemotherapeutic regimen gemcitabine/docetaxel (GEM/DOX) for treatment of relapsed and refractory pediatric sarcomas To determine the 6-month progression free survival achieved with this treatment in patients within cohorts of relapsed or refractory osteosarcoma, Ewing sarcoma, rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma. * To identify toxicities related to treatment with GEM/DOX + TGFβi expanded NK cells Participants will receive study drugs that include chemotherapy and NK cells in cycles; each cycle is 21 days long and you can receive up to 8 cycles. * Gemcitabine (GEM): via IV on Days 1 and 8 * Docetaxel (DOX): via IV on Day 8 * Prophylactic dexamethasone: Day 7-9 to prevent fluid retention and hypersensitivity reaction * Peg-filgrastim (PEG-GCSF) or biosimilar: Day 9 to help your white blood cell recover and allow more chemotherapy to be given * TGFβi NK cells: via IV on Day 12
This description comes directly from the study's public registry record.
Jessica Crimella, BSN, RN, CCRP · 813-745-6250 · jessica.crimella@moffitt.org
Always discuss trial participation with your own doctor first.
| University of Alabama | South Birmingham, Alabama, United States | Recruiting |
| Phoenix Children's Hospital | Phoenix, Arizona, United States | Recruiting |
| Arkansas Children's Hospital | Little Rock, Arkansas, United States | Recruiting |
| Children's Hospital of Los Angeles | Los Angeles, California, United States | Recruiting |
| Stanford University | Palo Alto, California, United States | Recruiting |
| University of Florida | Gainesville, Florida, United States | Recruiting |
| Nemours Jacksonville | Jacksonville, Florida, United States | Recruiting |
| University of Miami | Miami, Florida, United States | Recruiting |
| Johns Hopkins All Children's Hospital | St. Petersburg, Florida, United States | Recruiting |
| Washington University/St Louis Childrens | St Louis, Missouri, United States | Recruiting |
| Roswell Park Comprehensive Cancer Center | Buffalo, New York, United States | Recruiting |
| Montefiore Medical Center | The Bronx, New York, United States | Recruiting |
+ 10 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05634369