Hu14.18-Interleukin-2 Fusion Protein in Treating Patients With Advanced Melanoma
Melanoma (Skin)
About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring recurrent melanoma, stage IV melanoma
Eligibility Criteria
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
Sites / Locations
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
Hu14.18-IL2 Treatment
Hu14.18-IL2 will be given on days 1, 2, and 3 of each course of therapy as a 4 hour continuous IV infusion at a daily dose of 6 mg/m2. Treatment courses will be repeated every 28 days at the same dose.