Low-dose IL-2 Plus IFN-alpha Immunotherapy as Adjuvant Treatment of Renal Carcinoma.

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to compare the efficacy (in terms of event-free survival and overall survival) of an adjuvant therapy with IFN-alpha plus low-dose of IL2 vs a wait-and-see program in patient with radically operated renal cell carcinoma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Interleukin-2

Criteria

Inclusion Criteria:

• Diagnosis histologically confirmed of renal cells carcinoma (every histotype);

• Age < 75 years

• Radical surgical removal of the tumor: total or partial nephrectomy within previous 3 months

• Patient classified as T1 (with diameter > 2,5 cm), T2, T3 a-b-c; In presence of involvement of loco-regional lymph-nodes (staging N1, N2, N3, TNM class.), metastases should have been completely removed during nephrectomy

• Absence of distant metastases;

• Written informed consent

Exclusion Criteria:

• Tumor diameter equal or less than 2,5 cm;

• Previous chemotherapy or ormonotherapy o immunotherapy;

• Renal insufficiency >3 mg/dl);

• No symptomatic arrhythmias or autoimmune disease