A Pilot Study of the Effect of Genistein in Combination With High-Dose Interleukin-2 on Cell Expansion and Gene Expression in Patients With Metastatic Melanoma or Renal Cell Carcinoma

Inclusion 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