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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00502034
Recruitment Status : Completed
First Posted : July 17, 2007
Last Update Posted : July 10, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Carcinoma, Renal Cell Drug: Interferon Alfa-2a Drug: Interleukin-2 Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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).
Study Start Date : July 1994
Actual Primary Completion Date : April 2007
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A-immunotherapy
Immunotherapy with interferon-alpha and interleukin
Drug: Interferon Alfa-2a
Interferon Alfa-2a in combination with Interleukin

Drug: Interleukin-2
Interferon Alfa-2a in combination with Interleukin

No Intervention: B-follow-up

Primary Outcome Measures :
  1. Recurrence-free survival: loco-regional, adrenal, kidney and distant-metastases were the events considered for event-free survival.

Secondary Outcome Measures :
  1. Tolerability, toxicity and safety.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00502034

Carpi Hospital
Carpi, Modena, Italy, 41012
Ospedali Riuniti di Bergamo
Bergamo, Italy, 24128
Istituti Ospitalieri di Cremona
Cremona, Italy, 26100
Modena University Hospital
Modena, Italy, 41100
Parma University Hospital
Parma, Italy, 43100
Pavia University Hospital
Pavia, Italy, 27100
Ospedale "Guglielmo da Saliceto"
Piacenza, Italy, 29100
Arcispedale Santa Maria Nuova
Reggio Emilia, Italy, 42100
Sponsors and Collaborators
Gruppo Oncologico Italiano di Ricerca Clinica
Study Chair: Rodolfo Passalacqua, Medicine Gruppo Oncologico Italiano di Ricerca Clinica
Study Chair: Carlo Buzio, Medicine Parma University

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Gruppo Oncologico Italiano di Ricerca Clinica Identifier: NCT00502034     History of Changes
Other Study ID Numbers: POLAR 01
First Posted: July 17, 2007    Key Record Dates
Last Update Posted: July 10, 2013
Last Verified: July 2013

Keywords provided by Gruppo Oncologico Italiano di Ricerca Clinica:
Carcinoma, Renal Cell
Low-dose Interleukin
Adjuvant Immunotherapy

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Immunologic Factors
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents