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Sponsored by: |
National Institute on Deafness and Other Communication Disorders (NIDCD) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00021424 |
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.
Condition | Intervention | Phase |
---|---|---|
Head and Neck Cancer Metastatic Cancer |
Drug: recombinant fowlpox-TRICOM vaccine |
Phase I |
Study Type: | Interventional |
Study Design: | 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 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed stage IV squamous cell carcinoma of the oral cavity or oropharynx or nodal or dermal metastases for which current available treatment is not likely to offer a survival advantage or result in significant palliation
Local disease with unresectable distant metastases involving:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Neurologic:
Immunologic:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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) |
Study ID Numbers: | CDR0000068782, NCI-01-DC-0006, NCI-3210 |
Study First Received: | July 11, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00021424 |
Health Authority: | United States: Federal Government |
stage IV squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the oropharynx skin metastases |
Metronidazole Squamous cell carcinoma Dental Caries Recurrence Carcinoma Virus Diseases Epidermoid carcinoma |
Head and Neck Neoplasms Neoplasm Metastasis Carcinoma, squamous cell Neoplasms, Squamous Cell Carcinoma, Squamous Cell Carcinoma, squamous cell of head and neck Neoplasms, Glandular and Epithelial |
Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Site Neoplasms by Histologic Type |