Vaccine Therapy in Treating Patients With Stage IV Head and Neck Cancer
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have stage IV head and neck cancer.
Head and Neck Cancer
Biological: recombinant fowlpox-TRICOM vaccine
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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|
|Study Start Date:||June 2001|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00021424
|United States, Maryland|
|Warren Grant Magnuson Clinical Center|
|Bethesda, Maryland, United States, 20892-1182|
|Study Chair:||Susan Rudy, MSN||National Institute on Deafness and Other Communication Disorders (NIDCD)|