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

Gruppo Oncologico Italiano di Ricerca Clinica

Status and phase: Completed; Phase 3

Conditions: Carcinoma, Renal Cell

Treatments: Drug: Interferon Alfa-2a; Drug: Interleukin-2

Study type: Interventional

Funder types: Other

Identifiers

NCT00502034

POLAR 01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 310 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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310 participants in 2 patient groups

A-immunotherapy

Experimental group

Description:

Immunotherapy with interferon-alpha and interleukin

Treatment:

Drug: Interferon Alfa-2a

Drug: Interleukin-2

B-follow-up

No Intervention group

Description:

Wait-and-see