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

NCT ID: NCT00021424

Last Updated: 2015-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-06-30

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.

Conditions

Head and Neck Cancer; Metastatic Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

recombinant fowlpox-TRICOM vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: lead

Principal Investigators

Susan Rudy, MSN

Role: STUDY_CHAIR

National Institute on Deafness and Other Communication Disorders (NIDCD)

Locations

Warren Grant Magnuson Clinical Center

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

NCI-01-DC-0006

Identifier Type: -

Identifier Source: secondary_id

NCI-3210

Identifier Type: -

Identifier Source: secondary_id

CDR0000068782

Identifier Type: -

Identifier Source: org_study_id

NCT00006410

Identifier Type: -

Identifier Source: nct_alias