Reduced Intensity Haploidentical BMT for High Risk Solid Tumors
The purpose of this study is to see if giving reduced intensity chemotherapy, haploidentical bone marrow, post-transplant cyclophosphamide and shortened duration tacrolimus is safe and feasible for patients with very high-risk solid tumors.
| Condition(s) | Refractory and/or Relapsed Metastatic Solid Tumors |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | The purpose of this study is to see if giving reduced intensity chemotherapy, haploidentical bone marrow, post-transplant cyclophosphamide and shortened duration tacrolimus is safe and feasible for patients with very high-risk solid tumors. |
| Who can participate | Presence of a suitable related HLA-haploidentical bone marrow donor.a. The donor and recipient must be identical at at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1. A minimum match of 5/10 is therefore required, and will be considered sufficient evidence that the donor and recipient share one HLA haplotype. 1 year-50 years Patients must have a confirmed histopathologic diagnosis and be classified as high risk defined by having an expected survival of \< 10%. Examples include: * Neuroblastoma or ganglioneuroblastoma * Failure to achieve at least a PR after induction therapy with COG ANBL0532 or standard chemotherapy * Refractory to induction chemotherapy with COG ANBL0532 or standard chemotherapy * Patients with high risk disease as de |
| Ages | 1 Year to 50 Years |
| Sex | All |
| Lead sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| Locations | Baltimore, Maryland, United States; The Bronx, New York, United States; Valhalla, New York, United States |
| Start date | 2013-03-27 |
| NCT ID | NCT01804634 |
| Official listing | https://clinicaltrials.gov/study/NCT01804634 |