Trial | NCT00502034  Report issue

Title

Low-dose IL-2 Plus IFN-alpha Immunotherapy as Adjuvant Treatment of Renal Carcinoma.
Adjuvant Low-dose Interleukin-2 (IL2) Plus Interferone-alpha (IFN) in Operable Renal Cell Cancer (RCC). Phase III, Randomized, Multicenter Trial of the Italian Oncology Group for Clinical Research (GOIRC).

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    310
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.
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 Started
Jul 31
1994
Primary Completion
Apr 30
2007
Study Completion
Jun 30
2012
Last Update
Jul 10
2013
Estimate

Drug Interferon Alfa-2a

Interferon Alfa-2a in combination with Interleukin

Drug Interleukin-2

Interferon Alfa-2a in combination with Interleukin

A-immunotherapy Experimental

Immunotherapy with interferon-alpha and interleukin

B-follow-up No Intervention

Wait-and-see

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
No Results Posted