chemotherapy in treating patients with advanced kidney cancer

Conditions: Kidney Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of fenretinide in treating patients who have advanced kidney cancer.

objectives: * determine the response rate of patients with advanced renal cell carcinoma treated with fenretinide. * determine progression-free and overall survival of this patient population treated with this drug. * determine the quantitative and qualitative toxic effects of this drug in these patients. outline: patients receive oral fenretinide twice a day for 7 days. courses repeat every 21 days in the absence of unacceptable toxicity or disease progression. projected accrual: approximately 18-35 patients will be accrued for this study within 9-21 months.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed locally advanced unresectable, locally recurrent, or metastatic renal cell carcinoma * measurable disease * at least 20 mm with conventional techniques or * at least 10 mm with spiral ct scan * no nonmeasurable disease only including: * bone lesions * leptomeningeal disease * ascites * pleural/pericardial effusion * lymphangitis cutis/pulmonis * abdominal masses not confirmed and followed by imaging techniques * cystic lesions * no known brain metastases * history of brain metastases that have been resected and/or irradiated with subsequent normal brain ct scan allowed patient characteristics: age: * 18 and over performance status: * ecog 0-2 or * karnofsky 60-100% life expectancy: * more than 12 weeks hematopoietic: * absolute neutrophil count at least 1,500/mm3 * platelet count at least 100,000/mm3 hepatic: * bilirubin no greater than 1.5 mg/dl * ast no greater than 2.5 times upper limit of normal renal: * creatinine no greater than 2 mg/dl or * creatinine clearance at least 60 ml/min cardiovascular: * no symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia other: * not pregnant or nursing * fertile patients must use effective contraception * no other prior malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of any site * no history of allergic reactions attributed to compounds of similar chemical or biologic composition to fenretinide * no other concurrent uncontrolled illness (e.g., ongoing or active infection) * no concurrent psychiatric illness or social situation that would preclude study * history of hiv allowed if no active infection or history of retinitis * no history of retinal disease, night blindness, or difficulty seeing in the dark prior concurrent therapy: biologic therapy: * prior biologic therapy allowed chemotherapy: * no more than 1 prior chemotherapy regimen endocrine therapy: * not specified radiotherapy: * see disease characteristics * at least 4 weeks since prior radiotherapy surgery: * see disease characteristics other: * recovered from prior therapy * no prior systemic retinoid therapy * no concurrent antioxidants (e.g., ascorbic acid or vitamin e) * no other concurrent therapy for renal cell carcinoma

Keywords: stage iii renal cell cancer stage iv renal cell cancer recurrent renal cell cancer