Phase II Study of Intratumoral Injection of rF-TRICOMTM in Patients With Metastatic Melanoma Who Have Detectable Tumor Associated T Cells
I. Determine the safety and tolerability of intratumoral fowlpox-TRICOM in patients with
II. Determine the local response rate in patients treated with this agent. III. Determine
systemic clinical response in patients treated with this agent.
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
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
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Up to 15 years
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
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