Kidney Cancer
Conditions
Keywords
recurrent renal cell cancer, stage IV renal cell cancer
Brief summary
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill renal cell carcinoma (kidney cancer) cells. PURPOSE: This phase II trial is studying how well high-dose intravenous interleukin-2 works in treating patients with metastatic renal cell carcinoma that has not responded to previous low-dose intravenous or subcutaneous interleukin-2.
Detailed description
OBJECTIVES: * Determine the response rate (complete, partial, and minor) in patients with metastatic renal cell carcinoma who failed prior low-dose intravenous or subcutaneous interleukin-2 (IL-2) when treated with high-dose intravenous IL-2. * Determine the overall survival, disease-free survival, and time to progression in patients treated with this drug. * Determine the toxicity of this drug in these patients. OUTLINE: This is a pilot study. Patients receive high-dose interleukin-2 IV every 8 hours for 15 doses followed 7-10 days later by another 15 doses (course 1). Patients are assesed for response 2 months after initiation of treatment. Patients with responding or stable disease receive a second course of therapy. Patients with an ongoing response receive subsequent courses of treatment in the absence of unacceptable toxicity. Patients are followed every 6 months for survival. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Interventions
BIOLOGICALaldesleukin
Sponsors
Blumenthal Cancer Center at Carolinas Medical Center
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed