Clinical trial NCT00021424: Vaccine Therapy in Treating Patients With Stage IV Head and Neck Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Warren Grant Magnuson Clinical Center
state: Maryland
Study officials:
affiliation: National Institute on Deafness and Other Communication Disorders (NIDCD)
name: Susan Rudy, MSN
role: STUDY_CHAIR
References: