Vaccine Therapy in Treating Patients With Stage IV Head and Neck Cancer

NCT00021424 | Completed Phase 1

• 3 other identifiers: CDR0000068782NCI-01-DC-0006NCI-3210
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Metastatic Cancer

Keywords

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

Interventions

recombinant fowlpox-TRICOM vaccine BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute on Deafness and Other Communication Disorders (NIDCD): lead

Study Sites (1)

Warren Grant Magnuson Clinical Center

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Neoplasm Metastasis; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Susan Rudy, MSN

  National Institute on Deafness and Other Communication Disorders (NIDCD)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 11, 2001
• First Posted: January 27, 2003
• Study Start: June 1, 2001
• Last Updated: April 30, 2015

Record last verified: 2002-08

Locations

US (1)