Phase 2 STIR Trial: Haploidentical Transplant and Donor Natural Killer Cells for Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 20
Summary
- Conditions
- CNS Tumors
- Ewing Sarcoma
- Neuroblastoma
- Osteosarcoma
- Rhabdomyosarcoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Both males and females
Description
Patients will receive a reduced-intensity conditioning regimen for 6 days that consists of Fludarabine 150 mg/m2, Cyclophosphamide 29 mg/kg, and 3 Gy total body irradiation (TBI), followed by HLA-haploidentical marrow from a family member on Day 0. On Days +3 and +4, Cyclophosphamide 50 mg/kg will b...
Patients will receive a reduced-intensity conditioning regimen for 6 days that consists of Fludarabine 150 mg/m2, Cyclophosphamide 29 mg/kg, and 3 Gy total body irradiation (TBI), followed by HLA-haploidentical marrow from a family member on Day 0. On Days +3 and +4, Cyclophosphamide 50 mg/kg will be infused for selective in vivo T cell depletion. Additional post-grafting immune suppression will consist of mycophenolate mofetil and either tacrolimus or sirolimus. Non-mobilized peripheral blood mononuclear cells will be collected from donors on Day +6, from which NK cells will be selected and infused into patients on Day +7. Patients will be monitored for any transplant-related complications and will undergo disease monitoring every three months for the first two years post-transplant. Research studies will be conducted to follow the patient's immune status and quality of life post-transplant.
Tracking Information
- NCT #
- NCT02100891
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Monica Thakar, MD Medical College of Wisconsin