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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gruppo Oncologico Italiano di Ricerca Clinica
ClinicalTrials.gov Identifier:
NCT00502034
First received: July 16, 2007
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Carcinoma, Renal Cell
Drug: Interferon Alfa-2a
Drug: Interleukin-2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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).

Resource links provided by NLM:


Further study details as provided by Gruppo Oncologico Italiano di Ricerca Clinica:

Primary Outcome Measures:
  • Recurrence-free survival: loco-regional, adrenal, kidney and distant-metastases were the events considered for event-free survival. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability, toxicity and safety. [ Designated as safety issue: Yes ]

Enrollment: 310
Study Start Date: July 1994
Study Completion Date: June 2012
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Wait-and-see

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00502034

Locations
Italy
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
Investigators
Study Chair: Rodolfo Passalacqua, Medicine Gruppo Oncologico Italiano di Ricerca Clinica
Study Chair: Carlo Buzio, Medicine Parma University
  More Information

Additional Information:
Publications:
Responsible Party: Gruppo Oncologico Italiano di Ricerca Clinica
ClinicalTrials.gov Identifier: NCT00502034     History of Changes
Other Study ID Numbers: POLAR 01
Study First Received: July 16, 2007
Last Updated: July 9, 2013
Health Authority: Italy: Ministry of Health

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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Interferon-alpha
Interferons
Interleukin-2
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014