Clinical Trial: Viral Oncoprotein Targeted Autologous T Cell Therapy for Merkel Cell Carcinoma

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Viral Oncoprotein Targeted Autologous T Cell Therapy for Merkel Cell Carcinoma

Brief Summary: This phase I/II trial studies the side effects and best way to give laboratory treated autologous T cells together with aldesleukin and to see how well it works in treating patients with merkel cell carcinoma that has spread from the primary site (place where it started) to other places in the body. Biological therapies, such as cellular adoptive immunotherapy, may stimulate the immune system in different ways and stop tumor cells from growing. Aldesleukin may stimulate the white blood cells to kill tumor cells. Giving cellular adoptive immunotherapy with aldesleukin may be a better treatment for metastatic merkel cell carcinoma.

Detailed Summary:

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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.

OUTLINE:

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 at least every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.

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.

Sponsor: Fred Hutchinson Cancer Research Center

Current Primary Outcome:

  • 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 [ Time Frame: Up to 4 weeks ]
    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%.
  • Evidence of response based on "median time to new metastasis" [ Time Frame: Up to 4 years ]
    Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Disease response by RECIST criteria [ Time Frame: Up to 4 years ]
  • Functional capacity of transferred T cells [ Time Frame: Up to 4 years ]
  • MCC-specific survival [ Time Frame: Up to 4 years ]
  • Persistence of transferred T cells in blood and in tumor [ Time Frame: Up to 4 years ]


Original Secondary Outcome:

  • Persistence of transferred T cells in blood and in tumor [ Time Frame: Up to 4 years ]
  • Functional capacity of transferred T cells [ Time Frame: Up to 4 years ]
  • Disease response by RECIST criteria [ Time Frame: Up to 4 years ]
  • MCC-specific survival [ Time Frame: Up to 4 years ]


Information By: Fred Hutchinson Cancer Research Center

Dates:
Date Received: December 27, 2012
Date Started: February 2013
Date Completion:
Last Updated: April 17, 2017
Last Verified: April 2017