A Phase II Trial of Reduced Intensity Conditioning and Partially HLA-mismatched (HLA-haploidentical) Related Donor Bone Marrow Transplantation for High-risk Solid Tumors
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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.
Description
Allogeneic hematopoietic stem cell transplantation (HSCT) may be associated with a clinically significant "graft-versus-tumor" (GVT) effect, even against disease that is unresponsive to chemotherapy and radiation therapy. Graft-vs.-tumor (GVT) effects have been described after allogeneic HCT for neuroblastoma, Ewing sarcoma, osteosarcoma, rhabdomyosarcoma, melanoma and hepatoblastoma. The investigators' goal is to maximize a T cell and NK cell mediated graft versus tumor effect in poor prognosis solid tumor patients using haploidentical donors, T cell replete bone marrow, and a unique post-tr…
Eligibility
- Age range
- 1–50 years
- Sex
- All
- Healthy volunteers
- No
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 achi…
Interventions
- DrugCyclophosphamide
preparative regimen
- DrugFludarabine
- Radiationlow dose total body irradiation
- DrugMelphalan
- DrugTacrolimus
Locations (3)
- The Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland
- Albert Einstein College of Medicine, Children's Hospital at MontefioreThe Bronx, New York
- New York Medical Center/ Maria Fareri Children's HospitalValhalla, New York