Kidney Cancer
Conditions
Keywords
stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer
Brief 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.
Detailed description
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.
Interventions
DRUGfenretinide
Sponsors
National Cancer Institute (NCI)
Barbara Ann Karmanos Cancer Institute
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed