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

Overview

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 Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2007

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: A-immunotherapy
    • Immunotherapy with interferon-alpha and interleukin
  • No Intervention: B-follow-up
    • Wait-and-see

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Tolerability, toxicity and safety.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Gruppo Oncologico Italiano di Ricerca Clinica
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Rodolfo Passalacqua, Medicine, Study Chair, Gruppo Oncologico Italiano di Ricerca Clinica
    • Carlo Buzio, Medicine, Study Chair, Parma University

References

Passalacqua R, Buti S, Tomasello G, Longarini R, Brighenti M, Dalla Chiesa M. Immunotherapy options in metastatic renal cell cancer: where we are and where we are going. Expert Rev Anticancer Ther. 2006 Oct;6(10):1459-72. doi: 10.1586/14737140.6.10.1459.

Giacosa R, Santi R, Vaglio A, Pavone L, Ferrozzi F, Passalacqua R, Buzio C. "Late" regressions of metastases from renal cancer after a period of disease progression continuing the same intermittent low dose immunotherapy regimen. Acta Biomed. 2004 Aug;75(2):126-30.

Buzio C, Andrulli S, Santi R, Pavone L, Passalacqua R, Potenzoni D, Ferrozzi F, Giacosa R, Vaglio A. Long-term immunotherapy with low-dose interleukin-2 and interferon-alpha in the treatment of patients with advanced renal cell carcinoma. Cancer. 2001 Nov 1;92(9):2286-96. doi: 10.1002/1097-0142(20011101)92:93.0.co;2-i.

Buzio C, De Palma G, Passalacqua R, Potenzoni D, Ferrozzi F, Cattabiani MA, Manenti L, Borghetti A. Effectiveness of very low doses of immunotherapy in advanced renal cell cancer. Br J Cancer. 1997;76(4):541-4. doi: 10.1038/bjc.1997.422.

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