Phase I Dose-Escalation Study of the Pharmacokinetic, Safety, Tolerability, and Biologic Activity of huKS-IL-2 Administered Daily as a 1-Hour Intravenous Infusion for Five Consecutive Days for Treatment of Refractory Epithelial Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed epithelial carcinoma of 1 of the
following: Renal cell carcinoma Bladder carcinoma Lung carcinoma Refractory disease or
with no anticipated benefit from conventional treatment No brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: Platelet count at least 100,000/mm3 Hemoglobin at
least 10 g/dL WBC at least 3,500/mm3 OR Granulocyte count at least 2,000/mm3 Hepatic:
Bilirubin no greater than 3 times upper limit of normal (ULN) AST and ALT no greater than
3 times ULN Renal: Creatinine less than 2 times ULN Cardiovascular: Normal EKG No prior
myocardial infarction No arteriovenous block greater than I, complete hemiblock,
hypertrophy, or relevant arrhythmia No uncontrolled hypertension (diastolic at least 100
mmHg) or hypotension (systolic no greater than 90 mmHg) No prior episodes of syncope No
prior cardiac disease or significant risk factors for coronary artery disease, unless
there is no evidence of myocardial ischemia on exercise thallium scan or other exam (e.g.,
exercise EKG or dobutamine stress echocardiography) or there is no evidence of
significantly impaired left ventricular function on echocardiographic exam Normal thallium
scan if patient is at least 65 years old Pulmonary: Normal chest x-ray No pulmonary
congestion, pleural effusions, pulmonary fibrosis, or significant emphysema Other: No
concurrent infection No clinical evidence of immunosuppression No known hypersensitivity
to study drug, interleukin-2, Tween-80, or human immunoglobin No other condition that
would preclude study No Addison's disease No Crohn's disease Not pregnant or nursing
Negative pregnancy test Fertile patients must use effective contraception during and for 1
month after study Thyroid-sensitizing hormone no greater than 4.7 mU/L

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 30 days since prior biologic therapy
No other concurrent immunotherapy Chemotherapy: At least 30 days since prior chemotherapy
(6 weeks since mitomycin or nitrosoureas) No concurrent chemotherapy Endocrine therapy: At
least 30 days since prior endocrine therapy No concurrent systemic corticosteroid therapy
Radiotherapy: No prior radiotherapy to at least 25% of bone marrow At least 30 days since
prior radiotherapy At least 3 months since prior radioisotope therapy (e.g., strontium
chloride Sr 89 or samarium Sm 153 lexidronam pentasodium) No concurrent radiotherapy
Surgery: At least 3 weeks since prior major surgery No prior organ transplantation Other:
At least 30 days since prior investigational drug No prior therapy that would preclude
study No other concurrent investigational drugs No concurrent immunosuppressive therapy