A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFECT OF CISPLATIN/EPINEPHRINE INJECTABLE GEL (PRODUCT MPI 5010) WHEN ADMINISTERED INTRATUMORALLY FOR ACHIEVEMENT OF TREATMENT GOALS IN RECURRENT OR REFRACTORY SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the head and
neck that is recurrent or refractory following at least 1 course of therapy Primary or
metastatic tumors involving skin, nodes (palpable and biopsy- proven), subcutaneous
tissue, or muscle allowed No involvement of major artery or any visceral organ Measurable
lesions accessible for direct intratumoral injection with no immediate risk of hemorrhage
or embolization Most troublesome tumor (identified by the investigator) at least 0.5 cc
and no greater than 20 cc Smaller tumors eligible for treatment but not for efficacy
assessment An improvable primary treatment goal (palliative or preventive) for most
troublesome tumor must be identified by the investigator prior to enrollment If multiple
tumors qualify as most troublesome and share the primary physician-selected treatment
goal, the largest tumor is selected Patient may also select a most troublesome tumor and 1
palliative treatment goal for that tumor (need not match the physician-selected tumor or
goal) No fibrotic lesions (e.g., previously irradiated lesion with no subsequent disease
progression) No tumors involving or threatening to invade the carotid or other major
vessel

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60%-100% Life
expectancy: At least 6 months Hematopoietic: Absolute granulocyte count greater than
1,000/mm3 Platelet count greater than 75,000/mm3 Hepatic: Not specified Renal: Creatinine
no greater than 1.5 times normal Cardiovascular: No NYHA class III/IV status No history of
arrhythmia that would increase risk of treatment Other: No hypersensitivity to cisplatin,
bovine collagen, epinephrine, or sulfites No significant history of extracranial carotid
vascular disease from atherosclerosis, radiation therapy or previous carotid artery
surgery No uncontrolled local infection at treatment sites No medical or psychiatric
condition that would preclude informed consent No pregnant or nursing women Adequate
contraception required of fertile patients

PRIOR CONCURRENT THERAPY: More than 28 days since any antineoplastic therapy or therapy
with investigational agents Fully recovered from side effects of prior treatment