Carcinoma, Renal Cell
Conditions
Keywords
Carcinoma, Renal Cell, Low-dose Interleukin, Adjuvant Immunotherapy
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.
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
Interferon Alfa-2a in combination with Interleukin
DRUGInterleukin-2
Interferon Alfa-2a in combination with Interleukin
Sponsors
Gruppo Oncologico Italiano di Ricerca Clinica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence-free survival: loco-regional, adrenal, kidney and distant-metastases were the events considered for event-free survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| Tolerability, toxicity and safety. | — |
Countries
Italy
Outcome results
None listed