Clinical trial · Interventional
Interleukin-2 in Treating Patients With Stage III or Stage IV Kidney Cancer
A Randomized Controlled Phase III Adjuvant Trial of High-Dose Bolus IL-2 in Patients With High-Risk Renal Cell Carcinoma
NCT00003126CI-TRIAL-00025329completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to assess the efficacy of post-operative high-dose bolus interleukin-2 (IL-2) in patients with high-risk renal cell carcinoma (RCC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interleukin-2 | Drug | Aldesleukin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Interleukin-2 (IL-2)
- description
- Patients randomized to this arm will receive one course of IL-2 \[600,000 U/kg every 8 hours on post-operative days 1 to 5 and days 15 to 19 (maximum 28 doses)\].
- interventionNames
- Drug: Interleukin-2
- type
- NO_INTERVENTION
- label
- Observation
- description
- Patients randomized to this arm will receive their normal medical care
Primary outcomes (1)
- measure
- Disease free survival
- timeFrame
- 60 months
- description
- Disease free survival will be compared between the two cohorts (i.e., IL-2 versus Observation). Time will be calculated as the difference in months from date of treatment to date of death or recurrence (whichever occurs first). Patients remaining disease-free will be censored at the date of last follow-up.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria * An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate organ function as defined by a white blood cell (WBC) count of 4,000/L; a platelet count of 100,000/L; a Hemoglobin level of 10 g/dL; a serum creatinine of 1.5 mg/dL or creatinine clearance of 60 mL/min; and a direct bilirubin level of 1.5 mg/dL. * Forced expiratory volume at 1 second more than 2.0 L or 75% of predicted for height and age from pre-enrollment pulmonary function testing. * No history or evidence of cardiac disease on ECG * No prior systemic treatment for RCC, but patients may have received prior locoregional radiation therapy to solitary resectable metastases, which must have undergone surgical resection before enrollment. * No prior history of invasive malignancy in the past 5 years * Human immunodeficiency virus (HIV) negative * Female patients must not be pregnant or planning to become pregnant Exclusion criteria • Age younger than 16
References
Publications (25)
- BACKGROUNDJemal A, Murray T, Samuels A, Ghafoor A, Ward E, Thun MJ. Cancer statistics, 2003. CA Cancer J Clin. 2003 Jan-Feb;53(1):5-26. doi: 10.3322/canjclin.53.1.5. PMID 12568441
- BACKGROUNDSkinner DG, Colvin RB, Vermillion CD, Pfister RC, Leadbetter WF. Diagnosis and management of renal cell carcinoma. A clinical and pathologic study of 309 cases. Cancer. 1971 Nov;28(5):1165-77. doi: 10.1002/1097-0142(1971)28:53.0.co;2-g. No abstract available. PMID 5125665
- BACKGROUNDRobson CJ, Churchill BM, Anderson W. The Results of Radical Nephrectomy for Renal Cell Carcinoma. J Urol. 2017 Feb;197(2S):S111-S113. doi: 10.1016/j.juro.2016.10.095. Epub 2016 Dec 21. No abstract available. PMID 28012766
- BACKGROUNDMotzer RJ, Mazumdar M, Bacik J, Berg W, Amsterdam A, Ferrara J. Survival and prognostic stratification of 670 patients with advanced renal cell carcinoma. J Clin Oncol. 1999 Aug;17(8):2530-40. doi: 10.1200/JCO.1999.17.8.2530. PMID 10561319
- BACKGROUNDMessing EM, Manola J, Wilding G, Propert K, Fleischmann J, Crawford ED, Pontes JE, Hahn R, Trump D; Eastern Cooperative Oncology Group/Intergroup trial. Phase III study of interferon alfa-NL as adjuvant treatment for resectable renal cell carcinoma: an Eastern Cooperative Oncology Group/Intergroup trial. J Clin Oncol. 2003 Apr 1;21(7):1214-22. doi: 10.1200/JCO.2003.02.005. PMID 12663707
- BACKGROUNDPoster DS, Bruno S, Penta JS, Pinna K, Vilk P, Macdonald JS. Current status of chemotherapy, hormonal therapy, and immunotherapy in the treatment of renal cell carcinoma. Am J Clin Oncol. 1982 Feb;5(1):53-60. PMID 7081138
- BACKGROUNDFinney R. The value of radiotherapy in the treatment of hypernephroma--a clinical trial. Br J Urol. 1973 Jun;45(3):258-69. doi: 10.1111/j.1464-410x.1973.tb12152.x. No abstract available.