This trial is active, not recruiting.

Condition kidney cancer
Treatment aldesleukin
Phase phase 2
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose treatment

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).