A Phase II Study Of Mobilization Chemotherapy With GMCSF And GCSF Followed By High Dose Therapy Combined With IL2 Activated Autologous Peripheral Blood Stem Cells Followed By Sequential IL2 Therapy As Treatment For Solid Tumors And Lymphoma
- Determine the toxicity of sargramostim (GM-CSF) and filgrastim (G-CSF)-mobilized
interleukin-2(IL-2)-incubated autologous peripheral blood stem cells and sequential
IL-2 in patients with solid tumors or lymphoma.
- Determine the ability of cyclophosphamide and paclitaxel followed by GM-CSF and G-CSF
to mobilize adequate numbers of CD34+ cells and immune cells in these patients.
- Determine the time to neutrophil and platelet engraftment in patients treated with this
- Determine the overall and disease-free survival of patients treated with this regimen.
OUTLINE: Patients receive cyclophosphamide IV over 1-2 hours on day 1 and paclitaxel IV over
4 hours on day 2. Patients also receive sargramostim (GM-CSF) subcutaneously (SC) alone on
days 3-9 and GM-CSF and filgrastim (G-CSF) SC beginning on day 10 and continuing until
leukapheresis is completed.
Patients receive high-dose chemotherapy comprising oral busulfan every 6 hours on days -8 to
-6, melphalan IV on days -5 and -4, and thiotepa IV on days -3 and -2. Autologous peripheral
blood stem cells (PBSC) are treated ex vivo with interleukin-2 (IL-2) on day -1. Patients
undergo IL-2-treated autologous PBSC transplantation on day 0.
Beginning 4 hours after PBSC transplantation, patients receive IL-2 IV continuously for 5
days. IL-2 therapy repeats every 7 days for 4 courses.
Patients are followed on days 60-80, every 6 months for 2 years, and then annually
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 3 years.
Masking: Open Label, Primary Purpose: Treatment
Leona A. Holmberg, MD, PhD
Fred Hutchinson Cancer Research Center
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|