Clinical trial · Interventional
Interleukin-2 and Interferon in Treating Patients With Metastatic Kidney Cancer
Cytokines in the Treatment of Metastatic Renal Cell Carcinoma (MRCC): Intravenous Interleukin and Subcutaneous Interferon-α Versus Subcutaneous Interleukin and Interferon-α for Good Prognosis Patients [PERCY DUO]
- 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: Biological therapies, such as interleukin-2 and interferon, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether interleukin-2 given by infusion is more effective than interleukin-2 given by injection when combined with interferon in treating metastatic kidney cancer. PURPOSE: This randomized phase III trial is studying interleukin-2 given by infusion to see how well it works compared to interleukin-2 given by injection when combined with interferon in treating patients with 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| recombinant interferon alfa | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic renal cell adenocarcinoma * More than one resectable metastatic site * No unresectable lesions after local curative treatment (i.e., radiotherapy) * In case of secondary lesions suspected on imaging (\< 1 cm and/or sparse lesions), metastatic disease must be confirmed by biopsy OR disease progression documented by imaging performed over several weeks * If patient has known prior metastatic lesions, progressive disease must have been confirmed within the past 3 months by noninvasive techniques * Nephrectomized * Measurable or evaluable disease * No brain metastases PATIENT CHARACTERISTICS: * Karnofsky performance status 90-100% * Hematocrit ≥ 30% * WBC ≥ 4,000/mm\^3 * Platelet count ≥ 120,000/mm\^3 * Bilirubin normal * Creatinine ≤ 1.7 mg/dL * FEV\_1 ≥ 50% * No severe cardiac dysfunction (i.e., grade III/IV heart disease), including any of the following: * Congestive heart failure * Coronary artery disease * Uncontrolled hypertension * Severe arrhythmia * No active infections requiring antibiotic treatment * No severe neuropsychiatric condition * No geographical, psychological, or familial conditions that would preclude study treatment * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * LVEF ≥ 50% * No severe autoimmune disease * No known chronic hepatitis * No HIV positivity * No hepatitis B surface antigen positivity * No prior or concurrent other cancer, except basal cell skin cancer or carcinoma in situ of the cervix * No severe pulmonary, hepatic, or renal condition that would preclude study treatment PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 6 weeks since prior wide-field radiotherapy * No prior allograft * No prior cytokines or chemotherapy * No concurrent corticosteroids
References
Publications (1)
- RESULTNegrier S, Perol D, Ravaud A, Bay JO, Oudard S, Chabaud S, Fargeot P, Delva R, Deplanque G, Gravis G, Escudier B; French Immunotherapy Group. Randomized study of intravenous versus subcutaneous interleukin-2, and IFNalpha in patients with good prognosis metastatic renal cancer. Clin Cancer Res. 2008 Sep 15;14(18):5907-12. doi: 10.1158/1078-0432.CCR-08-0236. PMID 18794104