Study Summary
This trial will study if adding NK cells to chemo can improve outcomes in kids w/ sarcomas that haven't responded to prior treatments.
Eligible Conditions
- Pediatric Relapsed Sarcoma
- Refractory Pediatric Sarcoma
Treatment Effectiveness
Phase-Based Effectiveness
Phase 1 & 2
Study Objectives
2 Primary · 2 Secondary · Reporting Duration: 3-5 years
3-5 years
Frequency and characterization of DLT in study patients
Part 1
Part 2
Day 21
Exploratory Endpoint
Year 5
Treatment response of target lesions determined using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
1 Treatment Group
Treatment
1 of 1
Experimental Treatment
50 Total Participants · 1 Treatment Group
Primary Treatment: Treatment · No Placebo Group · Phase 1 & 2
Treatment
Biological
Experimental Group · 1 Intervention: GEM/DOX + TGFBi expanded NK cells · Intervention Types: BiologicalTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3-5 years
Who is running the clinical trial?
National Pediatric Cancer FoundationOTHER
4 Previous Clinical Trials
160 Total Patients Enrolled
2 Trials studying Sarcoma
122 Patients Enrolled for Sarcoma
Nationwide Children's HospitalLead Sponsor
319 Previous Clinical Trials
5,217,546 Total Patients Enrolled
1 Trials studying Sarcoma
86 Patients Enrolled for Sarcoma
Bhuvana Setty, MDPrincipal InvestigatorNationwide Children's Hospital
Eligibility Criteria
Age 12 - 40 · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:It's unclear what this criterion is referring to. Can you please provide more information?
You are taking chemotherapy medications that are not part of the study.
You can join the study if you have a history of seizures, but only if you are taking anti-seizure medication and have your seizures under control. However, you cannot participate if you are taking diazepam because it can affect the activity of certain immune cells.