Evaluation of M40403 for the Prevention of Dose Limiting Toxicities of High Dose IL-2

Inclusion Criteria: Patient has given signed informed consent. Patient has documented histologically confirmed malignant melanoma or renal cell carcinoma which is metastatic. Patient is eligible for high dose IV IL-2 therapy. Tumor dimension of at least one lesion is measurable in two dimensions. Patient is at least 18 years of age. Patient is ambulatory with good performance status (ECOG PS 0,1; Karnofsky 100-70%). If the patient is a woman of child bearing potential, patient is not lactating and ahs a negative pregnancy test (beta-HCG test obtained within 72 hours of enrollment) and agrees to use an adequate method of contraception for the duration of the study. Patient has adequate organ function as defined by: WBC count >3,500 per cubic millimeter; platelet count> 100,000 per cubic millimeter; Bilirubin within institutional normal range; creatinine less than or equal to 2.0 mg/dl or creatinine clearance > 50 ml/min; No evidence of congestive heart failure, symptoms of coronary artery disease, serious cardiac arrhythmias or evidence of prior myocardial infarction. A pretreatment cardiac stress test must be performed within 42 days of IL-2 treatment. Patients with documented ischemia on the pretreatment cardiac stress test will be excluded from the study; Adequate pulmonary reserve. Pulmonary function tests (PFTs) must be performed within 42 days of IL-2 treatment and an FEV1 > 2.0 liters or 75% of predicted for height and age is the minimum acceptable criteria for patient entry. PAtients unable to perform PFTs will be excluded from the study. Patient has recovered from all toxic effects of prior therapy. Patient has a life expectancy, in the opinion of the investigator, of at least 4 months. Exclusion Criteria: Patient has an organ allograft. Patient has brain metastases. A Brain CT or MRI scan should be performed within 42 days of IL-2 treatment. Patient is know to be HIV antibody positive. HIV testing is not required for enrollment into this study. Patient has evidence of active infection which requires antibiotic therapy. Patient has received systemic corticosteroids in the four weeks prior to the first dose of study drug, or requires or is anticipated to require corticosteroids for intercurrent disease. Patient has received radiotherapy, chemotherapy, or immunotherapy in the four weeks prior to the first dose of study drug, or is scheduled to receive concurrent radiotherapy, chemotherapy, or immunotherapy. Patient has contraindication to treatment with pressor agents. Patient currently receives chronic medication for asthma. Patient has a history of another malignancy other than basal cell skin cancer within 5 years prior to the first dose of study drug. Patient has any significant medical disease other than the malignancy which, in the opinion of the investigator, may interfere with completion of the study. Patient has previously received any IL-2 therapy. Patient has received another investigational medication within 4 weeks prior to M40403 administration or is scheduled to receive an investigational drug other than M40403 during the course of the study.