Phase 2 STIR Trial: Haploidentical Transplant and Donor Natural Killer Cells for Solid Tumors — STIR  

Neuroblastoma Clinical Trial

Official title: Phase 2 Solid Tumor Immunotherapy Trial Using HLA-Haploidentical Transplant and Donor Natural Killer Cells: The STIR Trial

Status Completed

Clinical Trial Summary

The investigators hypothesize that this Phase 2 cellular and adoptive immunotherapy study using human leukocyte antigen (HLA)-haploidentical hematopoietic cell transplantation (HCT) followed by an early, post-transplant infusion of donor natural killer (NK) cells on Day +7 will not only be well-tolerated in this heavily-treated population (safety), but will also provide a mechanism to treat high-risk solid tumors, leading to improved disease control rate (efficacy). Disease control rate is defined as the combination of complete (CR) and partial (PR) response and stable disease (SD). The investigators further propose that this infusion of donor NK cells will influence the development of particular NK and T cell subtypes which will provide immediate/long-term tumor surveillance, infectious monitoring, and durable engraftment.

Patients with high-risk solid tumors (Ewings Sarcoma, Neuroblastoma and Rhabdomyosarcoma) who have either measurable or unmeasurable disease and have met eligibility will be enrolled on this trial for a goal enrollment of 20 patients over 4 years.

Clinical Trial 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 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. ;

Related Conditions & MeSH terms

• Central Nervous System Neoplasms
• CNS Tumors
• Ewing Sarcoma
• Neuroblastoma
• Osteosarcoma
• Rhabdomyosarcoma
• Sarcoma
• Sarcoma, Ewing

• NCT number: NCT02100891
• Study type: Interventional
• Source: Medical College of Wisconsin
• Status: Completed
• Phase: Phase 2
• Start date: March 20, 2013
• Completion date: July 15, 2020