ALPHA INTERFERON AND CIS-RETINOIC ACID FOR THE TREATMENT OF SQUAMOUS CELL CARCINOMAS

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma that has failed
standard local modalities for local disease and/or effective systemic therapy for
metastatic disease, or for which other forms of systemic therapy have been refused
Eligible sites include but are not limited to: Uterine cervix Head and neck Skin Esophagus
Lung Penis Measurable or evaluable disease required Measurable disease defined as
previously unirradiated disease reproducibly measurable in 2 dimensions by physical exam,
x-ray, CT, MRI, or other radiologic procedure Documented progressive disease in a
previously irradiated site is accepted as measurable Evaluable disease includes: Any
visible radiologic disease not measurable in 2 perpendicular diameters Elevated squamous
cell carcinoma antigen (SCCA) No active brain metastases Previously treated brain
metastases that have responded to therapy do not exclude, but CNS disease is not
considered measurable or evaluable

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Hematopoietic: WBC
at least 3,000 Platelets at least 100,000 Hct at least 30% Hepatic: Bilirubin less than
2.0 mg/dl PT normal PTT normal Renal: Creatinine less than 2.0 mg/dl Cardiovascular: No MI
within 6 months No CHF requiring medication No arrhythmia requiring medication Pulmonary:
Reasonable respiratory reserve required No requirement for supplemental oxygen No dyspnea
at rest Other: No chronic underlying immunodeficiency disease No HIV positivity No
pregnant patients (negative pregnancy test required) Adequate birth control required of
fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: No concomitant immunosuppressive drugs, e.g.,
cyclosporin Chemotherapy: At least 3 weeks since prior systemic chemotherapy with recovery
Endocrine therapy: No concomitant corticosteroids Radiotherapy: No prior radiotherapy to
measurable site unless disease progression is documented Surgery: Not specified