NCT01758458

Viral Oncoprotein Targeted Autologous T Cell Therapy for Merkel Cell Carcinoma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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. After completion of study treatment, patients are followed up every 3 months.

Conditions

• Recurrent Merkel Cell Carcinoma
• Stage IV Merkel Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Aldesleukin	Given SC
OTHER	Laboratory Biomarker Analysis	Correlative studies
BIOLOGICAL	MCPyV TAg-specific Polyclonal Autologous CD8-positive T Cells	Given IV
RADIATION	Radiation Therapy	Undergo radiation therapy
BIOLOGICAL	Recombinant Interferon Beta	Given intralesionally

Timeline

• Start date: 2013-02-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2013-01-01
• Last updated: 2017-04-19

Locations

1 site across 1 country: United States