Protocol IL-2001: A Multi-Center, Open-Label, Randomized Study of the Efficacy and Safety of Multiple Intratumoral Injections of hIl-2 Plasmid (1.8 mg) Formulated With DOTMA/Cholesterol [Ratio 1:0.5(-/+)] Liposomes in Patients With Unresctable or Recurrent/Refractory Squamous Cell Carcinoma of the Head and Neck

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed recurrent or refractory stage III or IV
squamous cell carcinoma of the head and neck Failed first line chemotherapy for advanced
or recurrent disease Measurable disease accessible to direct injection Tumor must not be
involving major blood vessels or obstructing the airway

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3 Hepatic: No active liver disease Transaminases no
greater than 3 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5
times ULN OR Creatinine clearance greater than 60 mL/min Cardiovascular: No New York Heart
Association class III or IV heart disease Pulmonary: No respiratory disease sufficient
enough to influence oxygenation of arterial blood Other: Not pregnant or nursing Negative
pregnancy test Fertile patients must use effective contraception At least 2 weeks since
prior infection No concurrent infection No active or clinically relevant viral illness No
clinical condition (e.g., effusions or ascites) that would preclude methotrexate
administration No known hypersensitivity to antimetabolite chemotherapeutic agents No
rheumatic or autoimmune disease No other concurrent malignancies requiring treatment

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior antitumor therapy with recombinant
DNA products including viral based gene therapy or bacterial plasmids At least 28 days
since prior immunotherapy and at least 14 days since complete recovery At least 14 days
since complete recovery from prior antiviral therapy No concurrent hematopoietic growth
factors (filgrastim (G-CSF) or sargramostim (GM-CSF)) No concurrent recombinant
interleukin-2 therapy Prior G-CSF or GM-CSF adjunct therapy allowed Chemotherapy: See
Disease Characteristics At least 28 days since prior chemotherapy and at least 14 days
since complete recovery No prior methotrexate Endocrine therapy: No concurrent
corticosteroids Radiotherapy: At least 28 days since prior radiotherapy and at least 14
days since complete recovery Surgery: No planned surgical resection Other: At least 14
days since complete recovery from prior antibiotic therapy No concurrent high dose
nonsteroidal antiinflammatories or immunosuppressive drugs At least 30 days since prior
investigational drugs