NCT00087373

Vaccine Therapy in Treating Patients With Metastatic Melanoma

Phase II Study of Intratumoral Injection of rF-TRICOMTM in Patients With Metastatic Melanoma Who Have Detectable Tumor Associated T Cells

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Vaccines may make the body build an immune response to kill tumor cells. Injecting a vaccine directly into a tumor may cause a stronger immune response and kill more tumor cells. This phase II trial is studying how well vaccine therapy works in treating patients with metastatic melanoma.

Detailed description

PRIMARY OBJECTIVES: I. Determine the safety and tolerability of intratumoral fowlpox-TRICOM in patients with metastatic melanoma. II. Determine the local response rate in patients treated with this agent. III. Determine systemic clinical response in patients treated with this agent. SECONDARY OBJECTIVES: I. Determine the increase in transgene expression of B7-1, leukocyte function-associated antigen-3 (LFA-3), and intercellular adhesion molecule-1 (ICAM-1) in patients treated with this agent. II. Determine the effects of this agent on CD8-positive antitumor T-cell frequency as measured by tetramer and ELISpot in patients who are HLA-A2 positive. III. Correlate transgene expression of B7-1, LFA-3, and ICAM-1 by tumor cells with changes in function or number of melanoma antigen-specific CD8-positive T lymphocytes in patients treated with this agent. OUTLINE: This is a multicenter study. Patients receive fowlpox-TRICOM intratumorally on day 1 of weeks 1, 4, and 7 (maximum of 3 injections for a single lesion) (course 1). After 3 injections (course 1), patients with stable or responding disease receive additional injections into new lesions following the same schedule as above. Treatment repeats every 9 weeks for a maximum total of 9 injections (3 injections total into a maximum of 3 different tumors) (total of 3 courses) in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then approximately every 6 months for 5-15 years. PROJECTED ACCRUAL: A total of 14-28 patients will be accrued for this study within 14-28 months.

Conditions

• Recurrent Melanoma
• Stage IV Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	recombinant fowlpox-TRICOM vaccine	Given intratumorally
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2004-06-01
• Primary completion: 2006-02-01
• First posted: 2004-07-12
• Last updated: 2014-06-09

Locations

1 site across 1 country: United States