Treatment for Sarcoma

University of Texas MD Anderson Cancer Center, Houston, TX
Sarcoma+1 More ConditionsGEM/DOX + TGFBi expanded NK cells - Biological
12 - 40
All Sexes

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

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

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

1 of 1

Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: Treatment · No Placebo Group · Phase 1 & 2

Experimental Group · 1 Intervention: GEM/DOX + TGFBi expanded NK cells · Intervention Types: Biological

Trial 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.