High-Dose Intravenous Interleukin-2 in Treating Patients With Metastatic Renal Cell Carcinoma (Kidney Cancer) That Has Not Responded to Previous Low-Dose Intravenous or Subcutaneous Interleukin-2
Kidney Cancer
About this trial
This is an interventional treatment trial for Kidney Cancer focused on measuring recurrent renal cell cancer, stage IV renal cell cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed renal cell carcinoma Metastatic disease No pure papillary or sarcomatoid variants Measurable disease Failed prior subcutaneous OR intravenous (dose ≤ 50,000 IU/kg/day) interleukin-2 Documented disease progression No estimated hepatic replacement by tumor > 25% by CT scan or MRI No tumor involving the CNS or a major nerve PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 80-100% Life expectancy More than 3 months Hematopoietic Platelet count ≥ 80,000/mm^3 No sites of ongoing bleeding Hepatic See Disease Characteristics Bilirubin ≤ 1.4 mg/dL AST and ALT ≤ 3 times normal PT or PTT INR ≤ 1.2 Hepatitis B surface antigen negative Hepatitis C virus negative No coagulation disorders Renal Creatinine ≤ 1.6 mg/dL Cardiovascular No ongoing ischemia* No cardiac dysfunction* No abnormal ejection fraction* NOTE: *A cardiac stress test is indicated for all patients ≥ 50 years of age and for any patient with possible cardiac disease as suggested by history, physical exam, or electrocardiogram Pulmonary FEV_1 ≤ 65% of predicted* Vital capacity ≤ 65% of predicted* NOTE: *Pulmonary function tests are to be performed on any patient with a significant smoking history or suspected pulmonary disease either by history, physical exam, or radiograph Other HIV negative No AIDS No systemic infections No other malignancy except carcinoma in situ No psychiatric illness that would preclude study participation or compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics Chemotherapy Not specified Endocrine therapy No concurrent steroids Radiotherapy Not specified Surgery Not specified Other More than 28 days since other prior treatment for renal cell cancer No concurrent immunosuppressive agents
Sites / Locations
- Blumenthal Cancer Center at Carolinas Medical Center