Sequential ATRA Then IL-2 for Modulation of Dendritic Cells and Treatment of Metastatic Renal Cell Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed renal cell cancer
• •* Stage IV disease
• •* Histology with clear cell component
• •Metastatic OR incompletely resected disease
• •Non-measurable disease allowed
• •Underwent complete or partial nephrectomy more than 90 days ago
• •* No unresected primary cancer
• •No more than 2 of the following adverse factors:
• •* Hemoglobin \< 10.0 g/dL
• •* Corrected calcium \> upper limit of normal (ULN)
• •* Lactic dehydrogenase \> 1.5 times ULN
• •* Eastern Cooperative Oncology Group (ECOG) performance status 2
• •Brain metastasis allowed provided more than 90 days of clinical and radiologic stability after the end of its active treatment
• •PATIENT CHARACTERISTICS:
• •Age
• •Over 18
• •Performance status
• •See Disease Characteristics
• •ECOG 0-2
• •Life expectancy
• •Not specified
• •Hematopoietic
• •See Disease Characteristics
• •Hepatic
• •See Disease Characteristics
• •Serum glutamic oxaloacetic transaminase (SGOT) \< 3 times normal
• •Bilirubin \< 2 times normal
• •Renal
• •See Disease Characteristics
• •Creatinine clearance \> 40 mL/min
• •Cardiovascular
• •None of the following cardiovascular conditions within the past year:
• •* Uncontrolled hypertension
• •* Myocardial infarction
• •* Unstable angina
• •* New York Heart Association class II-IV congestive heart failure
• •* Serious cardiac arrhythmia requiring medication
• •* Class II-IV peripheral vascular disease within the past year
• •* Other clinically significant cardiovascular disease
• •Immunologic
• •No history of immunodeficiency disease
• •No HIV infection
• •No ongoing serious infection
• •Other
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use two methods of effective contraception during and for 1 month (for women) or 6 months (for men) after study treatment
• •Other prior malignancy allowed provided there is no evidence of active disease
• •No other medical contraindication to tretinoin or interleukin-2
• •No serious non-healing wound, ulcer, or bone fracture
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •At least 60 days since prior immunotherapy
• •Chemotherapy
• •At least 60 days since prior cytotoxic chemotherapy
• •Endocrine therapy
• •See Radiotherapy
• •No prior corticosteroids at \> physiologic replacement doses for \> 3 days within the past 90 days
• •Concurrent tamoxifen, toremifene, megestrol, or gonadotropin-releasing hormone agonists allowed
• •Concurrent inhaled steroids allowed
• •Radiotherapy
• •More than 7 days since prior external-beam radiotherapy
• •* No steroid requirement during radiotherapy
• •Surgery
• •See Disease Characteristics
• •At least 30 days since other prior debulking surgery
• •Other
• •Prior adjuvant therapy for resected, synchronous stage IV disease allowed
• •Prior adjuvant therapy allowed
• •* Study therapy is not to be used as adjuvant therapy for completely resected late (\> 1 year until identification) solitary site of disease metastasis or non-metastatic disease
• •No prior participation in this clinical study
• •At least 60 days since other prior anticancer drugs
• •Concurrent seizure medication allowed