Clinical trial · Interventional
Interferon Alfa With or Without Interleukin-2 and Fluorouracil in Treating Patients With Advanced Metastatic Kidney Cancer
A Randomized Controlled Trial of Interferon-alpha, Interleukin-2 and 5-Fluorouracil vs. Interferon-alpha Alone in Patients With Advanced Renal Cell Carcinoma
- 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)
RATIONALE: Interferon alfa may interfere with the growth of tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining interferon alfa with interleukin-2 and fluorouracil may kill more tumor cells. It is not yet known whether interferon alfa is more effective with or without interleukin-2 and fluorouracil in treating metastatic kidney cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa combined with interleukin-2 and fluorouracil to that of interferon alfa alone in treating patients who have advanced metastatic kidney cancer.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| recombinant interferon alfa | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Survival
Secondary outcomes (4)
- measure
- Time to progression as measured by RECIST criteria
- measure
- Comparison of toxicity levels (Grade III and IV)
- measure
- Comparison of quality of life before, during, after completion of study treatment
- measure
- Impact of the treatment regimens on health economics
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 81 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed renal cell carcinoma * Advanced metastatic disease that requires treatment * Measurable disease (single bone lesions not included) * No brain metastasis PATIENT CHARACTERISTICS: Age * 18 to 81 Performance status * WHO 0-1 Life expectancy * More than 12 weeks Hematopoietic * WBC greater than 3,000/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 10 g/dL Hepatic * Not specified Renal * Not specified Cardiovascular * No myocardial infarction within the past 6 months * No unstable angina pectoris Other * Not pregnant or nursing * Fertile patients must use effective contraception during and for at least 6 months after study participation * No other concurrent disease or prior malignancy that would preclude study treatments or comparisons * No concurrent active infection requiring antibiotics PRIOR CONCURRENT THERAPY: Biologic therapy * No prior biologic therapy Chemotherapy * No prior chemotherapy Endocrine therapy * No prior endocrine therapy * No concurrent corticosteroids Radiotherapy * At least 4 weeks since prior radiotherapy Surgery * Prior resection of the primary tumor recommended but not required * No prior major organ allografts
References
Publications (2)
- RESULTGore ME, Griffin CL, Hancock B, Patel PM, Pyle L, Aitchison M, James N, Oliver RT, Mardiak J, Hussain T, Sylvester R, Parmar MK, Royston P, Mulders PF. Interferon alfa-2a versus combination therapy with interferon alfa-2a, interleukin-2, and fluorouracil in patients with untreated metastatic renal cell carcinoma (MRC RE04/EORTC GU 30012): an open-label randomised trial. Lancet. 2010 Feb 20;375(9715):641-8. doi: 10.1016/S0140-6736(09)61921-8. Epub 2010 Feb 10. PMID 20153039
- RESULTGore ME: Interferon-α (IFN), interleukin-2 (IL2) and 5-fluorouracil (5FU) vs IFN alone in patients with metastatic renal cell carcinoma (mRCC): results of the randomised MRC/EORTC RE04 trial. [Abstract] J Clin Oncol 26 (Suppl 15): A-5039, 2008.