Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
NCT ID: NCT00018941
Last Updated: 2013-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
1991-04-30
2003-05-31
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of interleukin-2 in treating patients who have metastatic kidney cancer.
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Detailed Description
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OUTLINE: This is a randomized study. Patients are stratified according to presence of renal tumor (yes vs no). Patients are randomized to one of three treatment arms. Arm I: Patients receive low dose interleukin-2 (IL-2) IV every 8 hours for up to 15 doses. Treatment repeats in 7-10 days for one complete course. Arm II: Patients receive high dose IL-2 IV every 8 hours for up to 15 doses. Treatment repeats in 7-10 days for one complete course. Arm III: Patients receive IL-2 subcutaneously daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease receive an additional complete course of therapy.
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
Conditions
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Study Design
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TREATMENT
Interventions
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aldesleukin
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: More than 3 months Hematopoietic: Not specified Hepatic: Bilirubin less than 2.0 mg/dL AST and ALT no greater than 3 times normal Renal: Creatinine less than 1.6 mg/dL Cardiovascular: Normal EKG Normal thallium stress test (required of patients 50 years of age and older or as clinically indicated) Pulmonary: FEV1 and VC greater than 65% of predicted (pulmonary function screening required of patients with significant smoking history or suspicion of pulmonary disease) Other: No second malignancy, except: Basal cell skin cancer Carcinoma in situ of the cervix No significant psychiatric disease that would preclude consent or treatment No systemic infection No coagulation disorders or bleeding Not pregnant HIV negative
PRIOR CONCURRENT THERAPY: No prior therapy within 28 days Biologic therapy: No prior interleukin-2 Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No concurrent steroids
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Principal Investigators
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James C. Yang, MD
Role: STUDY_CHAIR
NCI - Surgery Branch
Locations
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Surgery Branch
Bethesda, Maryland, United States
Countries
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References
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Yang JC, Topalian SL, Parkinson D, Schwartzentruber DJ, Weber JS, Ettinghausen SE, White DE, Steinberg SM, Cole DJ, Kim HI, et al. Randomized comparison of high-dose and low-dose intravenous interleukin-2 for the therapy of metastatic renal cell carcinoma: an interim report. J Clin Oncol. 1994 Aug;12(8):1572-6. doi: 10.1200/JCO.1994.12.8.1572.
Other Identifiers
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NCI-91-C-0094
Identifier Type: -
Identifier Source: secondary_id
NCI-T91-0053N
Identifier Type: -
Identifier Source: secondary_id
CDR0000076799
Identifier Type: -
Identifier Source: org_study_id
NCT00001268
Identifier Type: -
Identifier Source: nct_alias
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