Kidney Cancer, Melanoma (Skin)
Conditions
Keywords
recurrent renal cell cancer, clear cell renal cell carcinoma, stage IV renal cell cancer, recurrent melanoma, stage IV melanoma
Brief 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.
Detailed description
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.
Interventions
Administered days 1-5, and 15-19; the patient will receive 600,000 IU/kg IL-2 by intravenous infusion over 15 minutes every 8 hours (on day 1 and day 15, patients will receive a maximum of 2 doses per day; on all other days in the cycle patients will receive a maximum of 3 doses per day)
Starting on day 10 and continuing through day 19, genistein will be administered orally at a dose of 600mg/day in two divided doses (i.e. 300mg po bid x 10 days)
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in peak and duration of the expansion of circulating CD4+, CD8+, and CD4+, CD25+, and CD56+ cells (dim and bright) | Days 1, 8, 10, 15, 22, and 24 of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Circulating plasma levels of TGF-beta | Prior to and at end of treatment |
Countries
United States