Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00502034
Status:
COMPLETED
Last Update Posted:
2013-07-10
First Post:
2007-07-16
Brief Title:
Low-dose IL-2 Plus IFN-alpha Immunotherapy as Adjuvant Treatment of Renal Carcinoma
Sponsor:
Gruppo Oncologico Italiano di Ricerca Clinica
Organization:
Gruppo Oncologico Italiano di Ricerca Clinica
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 sc IL2 5 dayswk 1 million UIsqm bid d 12 and 1 million UIsqm x 1 d 345 IFN 18 million UIsqm d 35 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 25 cm T2 T3 a-b-c pN0-pN3 M0 good cardiac and renal function and no autoimmune disease
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 sc IL2 5 dayswk 1 million UIsqm bid d 12 and 1 million UIsqm x 1 d 345 IFN 18 million UIsqm d 35 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 25 cm T2 T3 a-b-c pN0-pN3 M0 good cardiac and renal function and no autoimmune disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None