tretinoin plus interferon alfa in treating patients with metastatic kidney cancer

Conditions: Kidney Cancer

Summary: rationale: tretinoin may help kidney cancer cells develop into normal cells. interferon alfa may interfere with the growth of cancer cells. purpose: phase ii trial to study the effectiveness of liposomal tretinoin plus interferon alfa in treating patients who have metastatic kidney cancer.

objectives: * determine the response in patients with metastatic renal cell carcinoma treated with tretinoin liposome and interferon alfa-2b. * determine the toxicity of this regimen in these patients. * study retinoic acid receptor expression on tissue obtained from selected patients who have tumor biopsies. outline: this is a dose-escalation study of tretinoin liposome with concurrent individual dose escalation of interferon alfa-2b. (phase i closed to accrual as of 9/24/03.) patients receive tretinoin liposome iv over 30 minutes once weekly and interferon alfa-2b subcutaneously on five consecutive days (m-f) for 8 weeks. courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of tretinoin liposome until the maximum tolerated dose (mtd) has been determined. the mtd is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. once the mtd is determined additional patients are accrued and treated at that dose. (phase i closed to accrual as of 9/24/03.) during the first 3 weeks of the study, patients receive interferon alfa-2b at weekly dose escalations. after week 3, patients continue at the highest acceptable dose level of interferon alfa-2b for the remainder of the study. (phase i closed to accrual as of 9/24/03.) patients are followed at 30 days after the last treatment. projected accrual: a total of 3-18 patients will be accrued into the phase i portion of this study (phase i closed to accrual as of 9/24/03). a total of 14-25 patients will be accrued into the phase ii portion of this study.

Eligibility criteria:
disease characteristics: * histologically confirmed metastatic renal cell carcinoma * bidimensionally measurable disease * no active brain metastases patient characteristics: age: * 18 and over performance status: * karnofsky 60-100% life expectancy: * more than 3 months hematopoietic: * wbc at least 3,000/mm\^3 * platelet count at least 100,000/mm\^3 * no coagulation disorders hepatic: * bilirubin less than 1.5 mg/dl * sgot and sgpt less than 112.5 iu/l each or less than 2.5 times upper limit of normal * no clinically significant hepatic disease, including autoimmune hepatitis renal: * creatinine less than 2 mg/dl or * creatinine clearance greater than 50 ml/min * no clinically significant renal disease cardiovascular: * no clinically significant cardiac disease * no thrombophlebitis pulmonary: * no severe debilitating pulmonary disease * no pulmonary embolism other: * no history of diabetes mellitus prone to ketoacidosis * no known hypersensitivity to retinoids or retinoic acid derivatives or to interferon or any component of the injection for this study * no thyroid abnormalities that hinder maintaining thyroid function at the normal range * no severe infection * no severe malnutrition * no clinically significant retinal abnormalities * no pre-existing psychiatric condition, especially depression or a history of severe psychiatric disorder * no other concurrent malignancy except nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix * not pregnant or nursing * negative pregnancy test * fertile patients must use 2 effective methods of contraception during and for 1 month after study participation prior concurrent therapy: biologic therapy: * no more than 1 prior biological response modifier therapy or immunotherapy chemotherapy: * no more than 1 prior chemotherapy regimen endocrine therapy: * no concurrent steroids radiotherapy: * at least 4 weeks since prior radiotherapy surgery: * at least 4 weeks since prior major surgery other: * no prior retinoid therapy

Keywords: stage iv renal cell cancer recurrent renal cell cancer