Study to Evaluate Cellular Adoptive Immunotherapy Using Polyclonal Autologous CD8+ Antigen-Specific T Cells for Metastatic Merkel Cell Carcinoma
I. Determine the safety and potential toxicities associated with treating patients with
metastatic Merkel cell carcinoma (MCC) by combined myosin heavy chain (MHC) up-regulation
therapy and adoptive transfer of Merkel cell polyomavirus (MCPyV) T-antigen (TAg)-specific
polyclonal autologous cluster of differentiation (CD)8+ T cells.
II. Determine the antitumor efficacy associated with treating patients with metastatic MCC
by combined MHC up-regulation therapy and adoptive transfer of MCPyV TAg-specific polyclonal
autologous CD8+ T cells.
I. Determine the in vivo persistence and where evaluable, migration to tumor sites of
adoptively transferred polyclonal CD8+ T cells targeting the MCPyV TAg.
II. Determine the in vivo functional capacity of adoptively transferred polyclonal CD8+ T
cells targeting the MCPyV TAg.
Patients undergo radiation therapy or recombinant interferon beta intralesional injection
within day -3 to day -1.
Patients receive MCPyV TAg-specific polyclonal autologous CD8-positive T cell vaccine
intravenously (IV) on day 1 and aldesleukin subcutaneously (SC) every 12 hours on days 1-14.
Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or
Patients with continued presence of detectable metastatic disease 8 weeks after the first
infusion may repeat the treatment regimen including radiation therapy or recombinant
interferon beta injection.
After completion of study treatment, patients are followed up every 3 months.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evidence and nature of toxicity related to the study treatment assessed using National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0
The treatment will be considered to have an acceptable safety profile if the observed toxicity rate is consistent with a true rate that does not exceed 30%.
Up to 4 weeks
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|