Phase I Study To Evaluate Cellular Adoptive Immunotherapy Using Autologous IL-21 Modulated CD8+ Antigen-Specific T Cells For Patients With Metastatic Melanoma
I. Assess the safety and toxicity of adoptively transferred interleukin (IL)-21 modulated
cytotoxic T-lymphocyte (CTL) targeting a melanoma associated antigen in patients following
II. Evaluate the functional and numeric in vivo persistence of adoptively transferred IL-21
modulated CTL and factors contributing to immunopotentiation in patients receiving IL-21
modulated CTL following cyclophosphamide conditioning.
I. Evaluate the antitumor effect of adoptively transferred IL-21 modulated CD8+
antigen-specific CTL following cyclophosphamide conditioning and post-infusion IL-2.
Patients receive cyclophosphamide intravenously (IV) on days -3 and -2 followed by an
infusion of IL-21 modulated, melanoma antigen recognized by T cell (MART)-1 specific CD8+
cytotoxic T lymphocytes over 30-60 minutes on day 0. Beginning within 24 hours of T-cell
infusion, patients receive low-dose aldesleukin subcutaneously (SC) twice daily (BID) for 14
days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 8-10 weeks.
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 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 3.0
10 weeks post infusion
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Institutional Review Board
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|