genistein and interleukin-2 in treating patients with metastatic melanoma or kidney cancer

Conditions: Kidney Cancer; Melanoma (Skin)

Summary: rationale: genistein may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. interleukin-2 may stimulate the white blood cells, including natural killer cells, to kill melanoma or kidney cancer cells. giving genistein together with interleukin-2 may kill more tumor cells. purpose: this phase ii trial is studying how well giving genistein together with interleukin-2 works in treating patients with metastatic melanoma or kidney cancer.

objectives: primary * measure the differences in peak and duration of the expansion of circulating cd4-positive, cd8-positive, and cd4-, cd25-, and cd56-positive cells (dim and bright) at different time points during therapy with interleukin-2 (il-2) alone and plus genistein in patients with metastatic malignant melanoma or renal clear cell carcinoma. secondary * evaluate the differences in peripheral blood mononuclear cell gene expression following high-dose il-2 with and without genistein and compare to baseline. * determine the overall response rate (partial and complete) in patients treated with these regimens. * determine the safety and toxic effects of these regimens in these patients. * determine the time to progression in patients treated with these regimens. outline: this is a pilot study. patients receive high-dose interleukin-2 iv over 15 minutes twice daily on days 1 and 15 and 3 times daily on days 2-5 and 16-19. patients also receive oral genistein twice daily on days 10-19. after completion of study treatment, patients are followed periodically. projected accrual: a total of 15 patients will be accrued for this study.

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 \ 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

Keywords: recurrent renal cell cancer clear cell renal cell carcinoma stage iv renal cell cancer recurrent melanoma stage iv melanoma