NCT02653196 — drugset

There is currently no standard treatment for patients with neuro-epithelial (brain) or other solid tumors in another part of the body who do not have adequate suitable autologous hematopoietic progenitor cells available and/or whose disease has relapsed after standard treatment. Allogeneic Hematopoietic Progenitor Cell Transplant may be a consideration for treatment of patients with recurrent chemo-responsive malignant (high grade) neuro-epithelial and other solid tumors or those who do not have suitable autologous hematopoietic progenitor cell availability. The procedure in which your own blood stem cells are transplanted to you is called an autologous (from your own) progenitor cell transplant and when cells from a matched donor are transfused is called an allogeneic progenitor cell transplant. The study is being conducted to evaluate the safety and effectiveness of a combination of drugs followed by an allogeneic hematopoietic progenitor cell transplant (HPCT). This treatment regimen is experimental in that although the individual drugs are commonly used to treat your disease, the specific combination used in this protocol followed by the transplant is experimental.

Evaluation	Drug	Modality	Dose	Route
Subject	Alemtuzumab	Monoclonal antibody	12 mg/m2	Intravenous
Background	Cyclosporine	Peptide	3 mg/kg	Intravenous
Background	Cyclosporine	Peptide	6 mg/kg	Intravenous
Background	Etoposide	Small molecule	100 mg/m2	Intravenous
Background	Fludarabine	Small molecule	30 mg/m2	Intravenous
Background	Melphalan	Small molecule	70 mg/m2	Intravenous
Background	Mycophenolate Mofetil	Small molecule	15 mg/kg	Oral
Background	Palifermin	Protein / enzyme biologic	60 ug/kg	Intravenous
Background	Tacrolimus	Small molecule	0.05 mg/kg	Intravenous
Background	Thiotepa	Other / unclassified	300 mg/m2	Intravenous

Evaluation

Drug

Modality

Dose

Route

Subject

Alemtuzumab

Monoclonal antibody

12 mg/m2

Intravenous

Background

Cyclosporine