A Phase II, Multicenter, Open Label Study to Evaluate Effectiveness and Safety of AdCMV-p53 Administered by Intra-Tumoral Injections in 39 Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma of the head and
neck (SCCHN) Recurrent disease documented by histology or cytology (excluding
endolaryngeal recurrence) following first line therapy with curative intent, such as:
Radiation (at least 5000 cGy by standard methodology) and/or Surgery (definitive resection
with postoperative radiation as indicated) Lesions accessible to intratumoral injections
Bidimensionally measurable disease The sum of the products of the bidirectional
measurements for all bidimensionally measurable lesions must be not greater than 30 cm2
The sum of the longest diameters of all measurable lesions must be not greater than 10 cm
No CNS metastasis Tumor tissue from biopsy of primary or recurrent tumor must be available
to determine p53 mutation status

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: Greater than 12 weeks Hematopoietic: Platelet count at least 100,000/mm3
Absolute neutrophil count at least 2,000/mm3 Hepatic: Total bilirubin no greater than
upper limit of normal (ULN) AST/SGOT and/or ALT/SGPT no greater than 1.5 times ULN
Alkaline phosphatase no greater than 5 times ULN Renal: Not specified Other: Not pregnant
or nursing Barrier contraception required during treatment Negative for HIV 1, HIV 2,
hepatitis B, and hepatitis C At least 2 years since prior malignancy, other than SCCHN No
contact with former tissue or organ transplant recipients or persons with severe
immunodeficiency disease within 28 days following final dose of study drug No serious
concurrent medical conditions No active uncontrolled infection

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunostimulating drugs No prior
autologous or allogeneic organ or tissue transplant Chemotherapy: At least 4 weeks since
prior chemotherapy At least 6 weeks since nitrosourea or mitomycin No other concurrent
chemotherapy Endocrine therapy: No concurrent nontopical corticosteroids unless chronic
(at least 6 months) at low doses (no greater than 10 mg of oral prednisone) Radiotherapy:
See Disease Characteristics At least 4 weeks since radiotherapy to measurable disease
sites, unless progressive disease No concurrent radiotherapy to disease sites receiving
study drug injections Surgery: See Disease Characteristics No concurrent surgery to
disease sites receiving study drug injections Other: No concurrent high dose steroids At
least 4 weeks since experimental therapy No concurrent other experimental drugs or therapy
No prior gene therapy using adenoviral vectors