A Multi-Institutional Pilot Study of Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Malignant Neuro-Epithelial and Other Solid Tumors

Summary

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.

Conditions

• Neuroepithelial Tumor
• Solid Tumor
• Allogeneic Hematopoietic Stem Cell Transplantation

Interventions

PROCEDURE

Allogeneic hematopoietic stem cell transplant following thiotepa-based marrow ablative chemotherapy

Allogeneic hematopoietic stem cell transplant (HSCT) following thiotepa-based marrow ablative chemotherapy (MAC) for children with high-grade and/or recurrent neuro-epithelial and other solid tumors.

DRUG

Keratinocyte Growth Factor

KGF 60 mcg/kg IV: 6 doses

DRUG

Alemtuzumab

Alemtuzumab 12 mg/m2 IV: 2 doses (not given if matched related donor is 10/10 HLA matched sibling donor)

DRUG

Thiotepa

Thiotepa 300 mg/m2 IV: 3 doses

DRUG

Etoposide

Etoposide 100 mg/m2 IV: 3 doses

DRUG

Fludarabine

Fludarabine 30 mg/m2 IV: 3 doses

DRUG

Melphalan

Melphalan 70 mg/m2 IV: Day 2 doses

DRUG

Tacrolimus

Tacrolimus 0.05 mg/kg/day IV (Cyclosporine may be substituted for Tacrolimus): Start Day -2, begin taper on Day +100, discontinue on Day +180

DRUG

Cyclosporine A

Cyclosporine A dosed as follows: Age ≤ 6 years: 6 mg/kg/day IV in divided doses (e.g. 2 mg/kg every 8 hours) OR Age \> 6 years: 3 mg/kg/day IV in divided doses (1.5 mg/kg every 12 hours): Start Day -2, begin taper on Day +100, discontinue on Day +180

DRUG

Mycophenolate mofetil

Mycophenolate mofetil 15 mg/kg every 8 hours oral or IV: Start Day 0 (4-6 hours post stem cell infusion) to Day +40, then taper weekly until discontinuation on Day +90

Sponsors & Collaborators

• Children's Hospital Los Angeles

  collaborator OTHER

• Nationwide Children's Hospital

  collaborator OTHER

• Montefiore Medical Center

  lead OTHER

Principal Investigators

• Kris M Mahadeo, MD,MPH · The Children's Hospital at Montefiore

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-09-30

Primary Completion

2017-08-31

Completion

2017-08-31

Countries

• United States

Study Locations