Mechanism of Action of High-Dose IL-2 (Aldesleukin) in Metastatic Melanoma and Kidney Cancer
Metastatic Melanoma, Renal Cell Cancer
About this trial
This is an interventional treatment trial for Metastatic Melanoma focused on measuring Serum Protein Levels, Lymphocyte Phenotypes, Predictive Analysis, Serum Cytokines, Kidney Cancer, Renal Cell Cancer, Melanoma, Metastatic Melanoma
Eligibility Criteria
INCLUSION CRITERIA: Any patient with metastatic, measurable, histologically-proven RCC or melanoma who is a candidate for high-dose IL-2 therapy. Expected survival greater than three months. Age greater than or equal to18 years old. ECOG less than 2. Serum creatinine less than or equal to 1.4 mg/dl or creatinine clearance greater than or equal to 90 mL/min, and total bilirubin less than or equal to 2.0 mg/dl, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl. Platelet count greater than 100,000/mm(3). Absolute neutrophil count greater than 1000/mm(3). Serum ALT/AST less than three times the upper limit of normal. Must be willing to sign a durable power of attorney. Must be willing to practice effective contraception (regardless of gender). Must be willing to sign the informed consent document. EXCLUSION CRITERIA: Significant second malignancy within 3 years of protocol entry or likely to require intervention in the year following protocol entry. Significant psychiatric disease which in the opinion of the Principal Investigator would prevent adequate informed consent or render immunotherapy unsafe or contraindicated. Requirement for systemic or inhaled steroid administration (topical therapy is acceptable). Prior therapy within 28 days (except focal radiation for bone lesion). Systemic infections, coagulation disorders or evidence of active bleeding, or other major medical illnesses of the cardiovascular, respiratory or immune system. ECOG performance status greater than 2. Pregnancy. Previous IL-2 therapy. Positive HIV antibody titer, Seropositive for hepatitis B or C antigen. FEV1 or VC less than or equal to 65% of predicted (pulmonary function screening to be done in patients with significant smoking history [greater than 20pk/years] or suspicion of pulmonary disease by history or examination). Abnormal stress cardiac exam (to be done in all patients greater than or equal to 60 years old and others as indicated clinically) or active cardiac ischemia or significantly abnormal EKG. Greater than 25% estimated hepatic replacement by tumor or SGOT or SGPT greater than 3x normal. Untreated or clinically significant (i.e. because of size or presence of edema) tumor involvement of the CNS or major nerve compression.
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike