Phase I/II Study To Evaluate The Safety Of Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cell Clones Following CD25 Lymphodepletion For Patients With Metastatic Melanoma
I. Assess the safety of cellular adoptive immunotherapy in melanoma patients using
autologous CD8+ antigen-specific T-cell clones following CD25 lymphodepletion.
II. Determine the influence of CD25 lymphodepletion on the duration of in vivo persistence
of adoptively transferred CD8+ antigen-specific cytotoxic T-cell (CTL) clones.
I. Assess the anti-tumor efficacy of cellular adoptive immunotherapy in melanoma patients
using autologous CD8+ antigen-specific T cell clones following CD25 lymphodepletion.
II. Evaluate the induction of T cells to non-targeted tumor-associated antigens
(antigen-spreading) following adoptive transfer of CD8+ antigen-specific CTL and CD25
OUTLINE: This is a phase I study followed by a phase II study.
Patients receive autologous T-cell intravenously (IV) over 30-60 minutes on days 0 and 28
and low-dose aldesleukin subcutaneously (SC) twice daily on days 0 to 13 and 28 to 41.
Beginning 4-6 days before second T- cell infusion, patients receive denileukin diftitox IV
over 30 minutes on days 1-3. Treatment continues in the absence of disease progression or
After completion of study treatment, patients are followed up at 4 weeks, 8 weeks, and then
every 3 months thereafter.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
In vivo survival of CD8+ transferred T-clones
The design of this trial using the first infusion of CD8 T cells administered alone as a baseline for each patient permits intra-patient analysis using paired samples with increased statistical power.
Days +0, 1, 3, 7, 14, 22, 28, 29, 31, 35, 42, 49, 56, 63, 70, 77, 84
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|