Head and Neck Cancer Clinical Trial
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
Verified date | August 2002 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 - Unresectable locoregional recurrence after maximum radiotherapy OR - Local disease with unresectable distant metastases involving: - Base of skull - Prevertebral fascia - Deep neck muscles - Carotid artery (requiring resection) - Nasopharynx and/or pterygoid muscles - Ineligible to receive radiotherapy to head and neck during study - Primary intraoral lesions must be measurable and accessible to intralesional injections - No metastatic brain lesions, cerebral metastasis, or leptomeningeal disease PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Zubrod 0-2 Life expectancy: - At least 2 months Hematopoietic: - Absolute neutrophil count greater than 1,000/mm^3 - Platelet count greater than 100,000/mm^3 - Hemoglobin greater than 8 g/dL Hepatic: - Bilirubin less than 1.5 mg/dL - AST/ALT less than 4 times upper limit of normal (ULN) - PT/PTT less than 1.5 times ULN Renal: - Creatinine less than 2.0 mg/dL OR - Creatinine clearance greater than 60 mL/min Cardiovascular: - No evidence of congestive heart failure - No serious cardiac dysrhythmia - No evidence of recent prior myocardial infarction on EKG - No clinical coronary artery disease Neurologic: - No history of seizures or concurrent seizure disorder - No evidence of encephalitis, multiple sclerosis, or other structural brain lesion(s) by clinical or radiological evaluation Immunologic: - No risk of immune system compromise - HIV negative - No hypersensitivity to eggs - No significant history of allergies (e.g., anaphylaxis or angioedema) Other: - No active or chronic infection - No other serious concurrent medical illness - No other malignancy unless previously treated with curative intent and no evidence of persistent or recurrent disease - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior immunotherapy and recovered Chemotherapy: - No more than 2 prior chemotherapy regimens - At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: - At least 4 weeks since prior systemic corticosteroids - No concurrent systemic corticosteroids Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy and recovered - No prior radiotherapy to more than 50% of nodal groups Surgery: - More than 4 weeks since prior surgery for primary or metastatic lesions and recovered - No prior splenectomy |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Warren Grant Magnuson Clinical Center | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute on Deafness and Other Communication Disorders (NIDCD) |
United States,
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