Phase I Study To Evaluate Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cell Clones Following Cyclophosphamide Conditioning For Patients With Metastatic Melanoma
I. To assess the safety and toxicity of cellular adoptive immunotherapy in melanoma patients
using autologous CD4+ and CD8+ antigen-specific T cell clones.
II. To evaluate the antitumor effects of CD4+ and CD8+ antigen-specific T cells in patients
with metastatic melanoma.
III. To determine the duration of in vivo persistence of adoptively transferred CD8+
antigen-specific T cell clones in the presence or absence of transferred CD4+ T cells.
I. To assess the in vivo antitumor efficacy of the infused autologous antigen-specific CD4+
OUTLINE: This is a phase I study followed by a phase II study.
Beginning 48 hours before T-cell infusion, patients receive cyclophosphamide IV. Patients
then receive antigen-specific CD8+ T cells IV alone or with CD4+ T helper clones over 1-2
hours on day 0. Patients also receive aldesleukin subcutaneously twice daily on days 0-13.
Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or
After completion of study treatment, patients are followed up weekly for 8 weeks, and then
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and toxicity as assessed by NCI CTC version 3.0
8 weeks post treatment
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|