Chemotherapy in Treating Patients With Advanced Kidney Cancer
Chemotherapy in Treating Patients With Advanced Kidney Cancer
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.
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