Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Stage IV Head and Neck Cancer
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
NCT00021424CI-TRIAL-00017718completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| recombinant fowlpox-TRICOM vaccine | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 splenectomyReferences
Publications (0)
Data not yet available
No reference posted for this study.