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

Phase 3

Completed

• Conditions: Carcinoma, Renal Cell
• Interventions: Drug: Interferon Alfa-2a; Drug: Interleukin-2

• Registration Number: NCT00502034
• Lead Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica

Brief 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.

Detailed Description

For pts with non-metastatic RCC, no standard adjuvant treatment exists. Immunotherapy (IT) using IFN and/or IL2 is effective in metastatic disease setting. Low and chronically repeated doses of IL2 plus IFN induce a persistent stimulation of the immune system with no relevant toxicity.

Surgically treated RCC pts were randomized to the following arms: A) low-dose IT; B) control arm. IT consisted of a 4-week cycle of s.c. IL2 (5 days/wk, 1 million UI/sqm bid d 1,2 and 1 million UI/sqm x 1 d 3,4,5) + IFN (1,8 million UI/sqm d 3,5 of each week). Cycles were repeated every 4 months for the first 2 years and every 6 months for the remaining 3 years. Each patient received 12 cycles in 5 years. Inclusion criteria were as follows: histological diagnosis of RCC, age \<75 yrs, radical or partial nephrectomy within the past 3 months, pT1 (diameter of T \> 2,5 cm), T2, T3 a-b-c; pN0-pN3, M0; good cardiac and renal function and no autoimmune disease.

Study Timeline

• Study Start: 1994-07
• Primary Completion: 2007-04
• Study First Submitted: 2007-07-16
• Study First Submitted QC: 2007-07-16
• Study First Posted: 2007-07-17
• Study Completion: 2012-06
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-09
• Last Update Posted: 2013-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 310

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A-immunotherapy	Interleukin-2	Immunotherapy with interferon-alpha and interleukin
A-immunotherapy	Interferon Alfa-2a	Immunotherapy with interferon-alpha and interleukin

Primary Outcome Measures

Name	Time	Method
Recurrence-free survival: loco-regional, adrenal, kidney and distant-metastases were the events considered for event-free survival.

Secondary Outcome Measures

Name	Time	Method
Tolerability, toxicity and safety.

Trial Locations

Locations (8)

Pavia University Hospital; 🇮🇹 Pavia, Italy

Ospedale "Guglielmo da Saliceto"; 🇮🇹 Piacenza, Italy

Modena University Hospital; 🇮🇹 Modena, Italy

Istituti Ospitalieri di Cremona; 🇮🇹 Cremona, Italy

Carpi Hospital; 🇮🇹 Carpi, Modena, Italy

Ospedali Riuniti di Bergamo; 🇮🇹 Bergamo, Italy

Parma University Hospital; 🇮🇹 Parma, Italy

Arcispedale Santa Maria Nuova; 🇮🇹 Reggio Emilia, Italy