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
This trial is active, not recruiting.
|Sponsor||Blumenthal Cancer Center at Carolinas Medical Center|
|Start date||June 1998|
|Trial identifier||NCT00080977, CDR0000357581, CMC-10-01-01AH|
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.
Male or female participants at least 18 years old.
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
|Official title||Treatment of Patients With Metastatic Renal Cell Carcinoma Who Have Failed Low Dose Intensity Interleukin-2 With High-Dose Intravenous Recombinant Interleukin-2|
|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.|
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