A Phase I Study to Examine the Toxicity of Killer IG-Like Receptor (KIR) Mismatched Umbilical Cord Blood for Pediatric Patients With Malignant Solid Tumors
- Examine the impact of the use of killer cell immunoglobulin-like receptor
(KIR)-mismatched umbilical cord blood as a source of hematopoietic stem cells, after
busulfan, melphalan, and anti-thymocyte globulin in pediatric patients with relapsed or
refractory solid tumors.
- Determine the toxicity of this regimen, in terms of incidence of grade 3-4 acute
graft-versus-host disease, donor/host chimerism, and cellular immunity against tumor
cell lines, in these patients.
- Transplantation: Patients receive busulfan orally or IV every 6 hours on days -8 to -5,
anti-thymocyte globulin IV over 6 hours on days -4 to -1, and melphalan IV over 15-20
minutes on days -4 to -2. Patients undergo allogeneic umbilical cord blood stem cell
infusion on day 0. Patients receive sargramostim (GM-CSF) subcutaneously beginning on
day 7 and continuing until blood counts recover.
- Graft-vs-host disease prophylaxis: Patients receive cyclosporine IV over 1 hour or
orally twice daily on days -1 to 180 and methylprednisolone IV or orally once or twice
daily on days 5 - 49.
Blood samples are collected periodically for immunophenotyping and flow cytometric analysis
(including interferon gamma and other TH1 and TH2 cytokines).
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Kenneth G. Lucas, MD
Milton S. Hershey Medical Center
United States: Federal Government
|Penn State Cancer Institute at Milton S. Hershey Medical Center||Hershey, Pennsylvania 17033-0850|