Phase I/Pilot Study of Intralesional Immunotherapy With A Recombinant Avipox Virus Engineered To Express A Triad Of Co-Stimulatory Molecules In Patients With Advanced Squamous Cell Carcinoma Of The Head And Neck
- Determine the maximum tolerated dose and dose-limiting toxic effects of recombinant
fowlpox-TRICOM vaccine in patients with advanced squamous cell carcinoma of the oral
cavity or oropharynx or nodal or dermal metastases.
- Determine the safety profile of this regimen in these patients.
- Determine the clinical activity of this regimen, in terms of inflammation at injection
site(s) and disease regression or stabilization, in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive recombinant fowlpox-TRICOM vaccine (rF-TRI) intralesionally once on weeks
0, 3, and 8. Beginning on week 16, patients may receive additional rF-TRI once every 8 weeks
in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of rF-TRI until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3
or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at 1 year.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Primary Purpose: Treatment
Susan Rudy, MSN
National Institute on Deafness and Other Communication Disorders (NIDCD)
United States: Federal Government
|Warren Grant Magnuson Clinical Center||Bethesda, Maryland 20892-1182|