Genistein and Interleukin-2 in Treating Patients With Metastatic Melanoma or Kidney Cancer
Kidney Cancer, Melanoma (Skin)
About this trial
This is an interventional treatment trial for Kidney Cancer focused on measuring recurrent renal cell cancer, clear cell renal cell carcinoma, stage IV renal cell cancer, recurrent melanoma, stage IV melanoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Documented histologically confirmed malignant melanoma or renal clear cell carcinoma Metastatic disease At least 1 measurable lesion that can be accurately measured in at least one dimension with longest diameter > 20 mm using conventional techniques OR > 10 mm with spiral CT scan If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology Clinical lesions will only be considered measurable when they are superficial (e.g., skin nodules or palpable lymph nodes) The following are considered non-measurable lesions: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Inflammatory breast disease Lymphangitis cutis/pulmonis Cystic lesions Abdominal masses that are not confirmed and followed by imaging techniques No CNS metastases by CT scan or MRI PATIENT CHARACTERISTICS: ECOG performance status < 2 Life expectancy ≥ 4 months Serum creatinine < 2.0 mg/dL OR creatinine clearance > 50 mL/min Bilirubin normal Platelets > 100,000/mm³ WBC > 3,500/mm³ No evidence of congestive heart failure No symptom of coronary artery disease No serious cardiac arrhythmias A pretreatment cardiac stress test must be performed within 42 days of IL-2 treatment if any cardiac symptoms present (patients with documented ischemia on the pretreatment cardiac stress test will be excluded from the study) Adequate pulmonary reserve FEV_1 > 75% of predicted Not pregnant or nursing Fertile patients must use effective contraception Negative pregnancy test No known HIV-positive patients No evidence of active infection requiring antibiotic therapy No contraindication to treatment with pressor agents No significant medical disease which, in the opinion of the investigator, may interfere with completion of the study No history of another malignancy other than basal cell skin cancer within 5 years PRIOR CONCURRENT THERAPY: Recovered from all toxic effects of prior therapy No radiotherapy, chemotherapy, or immunotherapy in the 4 weeks prior to the first dose of the study treatment No systemic corticosteroids in the 4 weeks prior to treatment No previous investigational agent within 4 weeks prior to the start of the study No prior interleukin-2 therapy No organ allografts allowed No concurrent radiotherapy, chemotherapy, or immunotherapy No concurrent corticosteroids No concurrent chronic medication for asthma
Sites / Locations
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Arms of the Study
Arm 1
Experimental
Genistein and Interleukin-2