LMB-2 Immunotoxin and Vaccine Therapy in Treating Patients With Metastatic Melanoma That Cannot Be Removed By Surgery
Melanoma (Skin), Non-melanomatous Skin Cancer
About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring recurrent melanoma, stage IV melanoma, skin cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of metastatic melanoma Unresectable disease Progressive disease while receiving standard therapy (e.g., interleukin-2 or dacarbazine) HLA-A0201 positive Measurable disease The following are not allowed: Resectable local/regional disease Patients whose serum neutralizes LMB-2 in tissue culture, due either to antitoxin or antimouse-immunoglobulin G antibodies (> 75% of the activity of 1 ug/mL of LMB-2) Received LMB-2 on another trial PATIENT CHARACTERISTICS: ECOG performance status 0-2 Life expectancy more than 3 months WBC ≥ 3,000/mm^3 Absolute lymphocyte count > 500/mm^3 Platelet count ≥ 90,000/mm^3 Bilirubin ≤ 2.0 mg/dL (≤ 3.0 mg/dL for patients with Gilbert's syndrome) AST and ALT ≤ 2.5 times normal Albumin ≥ 3.0 g/dL No hepatitis B surface antigen or hepatitis C positivity Creatinine ≤ 1.4 mg/dL Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No ongoing or active infection Ejection fraction ≥ 45% by echocardiogram or thallium stress test (for patients > 50 years of age OR who have a history of cardiovascular disease) LVEF ≥ 45% No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia No psychiatric illness or social situation that would preclude study compliance No other uncontrolled illness No known HIV positivity No autoimmune disease No immunodeficiency No other malignancies Must be willing to undergo leukapheresis PRIOR CONCURRENT THERAPY: See Disease Characteristics More than 12 weeks since prior monoclonal antibody therapy More than 3 weeks since prior and no concurrent systemic therapy for cancer No concurrent chronic anticoagulant therapy No concurrent systemic steroid therapy
Sites / Locations
- Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
- NCI - Surgery Branch