Chemotherapy in Treating Patients With Advanced Kidney Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase Two Study Of Fenretinide In Renal Cell Cancer

Conditions
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Kidney Cancer

Intervention / Treatment
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* Drug: fenretinide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: fenretinide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer