A Phase I Study to Examine the Toxicity of Allogeneic Stem Cell Transplantation for Pediatric Solid Tumors With Relapsed or Therapy Refractory Disease
- Determine the toxicity of allogeneic hematopoietic stem cell transplantation, in terms
of the incidence of grade 3-4 acute graft-versus-host disease, in young patients with
relapsed or refractory solid tumors.
- Determine the incidence of transplant-related mortality at 100 days
post-transplantation in these patients.
- Conditioning: Patients receive busulfan IV or orally 4 times daily on days -8 to -5 (a
total of 16 doses) and melphalan IV over 15-20 minutes on days -4 to -2. Patients with
an unrelated donor also receive anti-thymocyte globulin IV on days -4 to -2.
- Allogeneic hematopoietic stem cell transplantation (SCT): Patients undergo allogeneic
hematopoietic SCT on day 0.
- Post-transplant graft-versus-host disease (GVHD) prophylaxis: Patients who undergo cord
blood SCT receive cyclosporine and methylprednisolone for graft-versus-host disease
(GVHD) prophylaxis. Patients who undergo peripheral blood or bone marrow SCT receive
cyclosporine and methotrexate (short course) for GVHD prophylaxis.
After completion of study treatment, patients are followed at 1, 3, 6, and 12 months and
then annually thereafter.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 4 years.
Masking: Open Label, Primary Purpose: Treatment
Kenneth G. Lucas, MD
Milton S. Hershey Medical Center
United States: Federal Government
|Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center||Hershey, Pennsylvania 17033-0850|