Vaccine Therapy in Treating Patients With Stage IV Head and Neck Cancer
- Conditions
- Metastatic CancerHead and Neck Cancer
- Registration Number
- NCT00021424
- Lead Sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Warren Grant Magnuson Clinical Center
🇺🇸Bethesda, Maryland, United States