Hu14.18-Interleukin-2 Fusion Protein in Treating Patients With Advanced Melanoma

DISEASE CHARACTERISTICS:

• Histologically confirmed malignant melanoma

  • Advanced disease
• Measurable disease by clinical assessment or imaging

• No known standard curative therapy exists

  • Disease no longer controlled by surgery, chemotherapy, or radiotherapy
• No clinically detectable pleural effusion or ascites
• No brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• WBC ≥ 3,500/mm^3 OR
• Granulocyte count ≥ 2,000/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 10.0 g/dL

Hepatic

• AST and ALT < 2 times normal
• Bilirubin < 2.0 mg/dL
• Hepatitis B surface antigen negative
• No clinical evidence of hepatitis

Renal

• Creatinine < 2.0 mg/dL OR
• Creatinine clearance ≥ 60 mL/min

Cardiovascular

• No ischemic cardiac disease, congestive heart failure, or myocardial infarction within the past 6 months
• No uncontrolled cardiac rhythm disturbance
• No myocardial ischemia or heart failure by exercise radionuclide scan for patients with a history of cardiac disease, significant risk factors for coronary artery disease, or ≥ 65 years of age

Pulmonary

• Pulmonary function normal by exercise radionuclide scan for patients with a history of cardiac disease, significant risk factors for coronary artery disease, or ≥ 65 years of age

Immunologic

• HIV negative
• No known hypersensitivity to the study drug, Tween-80®, or human immunoglobulin
• No uncontrolled active infection

Neurologic

• No seizure disorder
• No objective peripheral neuropathy ≥ grade 2
• No clinically significant neurologic deficit

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Must consent to the placement of a central venous line OR demonstrate stable peripheral IV access
• Must be willing and able to discontinue antihypertensive medications (if advised to do so) on the days of study drug infusion
• No uncontrolled active peptic ulcer
• No known grade 4 side effects related to prior interleukin-2
• No diabetes mellitus that has required systemic therapy (e.g., oral hypoglycemic agents or insulin) within the past 3 months
• No other significant illness
• No significant psychiatric disability

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Prior monoclonal antibodies for biologic therapy, tumor imaging, purging of autologous bone marrow/stem cells for re-infusion, or for any other reason allowed provided there is documented absence of detectable antibody to hu14.18 by serology
• No concurrent growth factors

Chemotherapy

• No immediate requirement for palliative chemotherapy
• No concurrent anticancer chemotherapy

Endocrine therapy

• More than 2 weeks since prior and no concurrent corticosteroids (e.g., dexamethasone)
• No immediate requirement for palliative hormonal therapy

Radiotherapy

• No immediate requirement for palliative radiotherapy

  • Concurrent palliative radiotherapy to localized painful lesions allowed provided ≥ 1 measurable or evaluable lesion is not irradiated AND the irradiated lesion is not used to assess tumor response

Surgery

• More than 3 weeks since prior major surgery
• No prior organ allografts

Other

• More than 2 weeks since other prior and no concurrent immunosuppressive drugs
• No prior standard or experimental systemic therapy for stage IV melanoma
• No concurrent myelosuppressive antineoplastic drugs