A Phase Two Study Of Fenretinide In Renal Cell Cancer

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