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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Given intratumorally
Correlative studies
University of Chicago
Chicago, Illinois, United States
Local response defined as complete response (CR), a partial response (PR) stable disease (SD), or progressive disease (PD) in the injected lesion according to RECIST criteria
Time frame: Up to 15 years
Overall clinical response (CR or PR) as measured by RECIST criteria
Time frame: Up to 15 years
Change in mRNA expression of B7-1, LFA-3, and/or ICAM-1in the tumor microenvironment
Changes in laboratory correlates pre- versus post- treatment will be analyzed using a paired t-test. The association between changes in these measurements and tumor response will be assessed by comparing the changes in responders and non-responders using a Wilcoxon rank-sum test.
Time frame: Baseline and week 10
Changes in tumor associated T cells
Changes in laboratory correlates pre- versus post- treatment will be analyzed using a paired t-test. The association between changes in these measurements and tumor response will be assessed by comparing the changes in responders and non-responders using a Wilcoxon rank-sum test.
Time frame: Baseline and week 10
Time to tumor progression
Time to tumor progression will be analyzed by the Kaplan-Meier method.
Time frame: Up to 15 years
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