Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003126
Status:
COMPLETED
Last Update Posted:
2017-01-04
First Post:
1999-11-01
Brief Title:
Interleukin-2 in Treating Patients With Stage III or Stage IV Kidney Cancer
Sponsor:
Loyola University
Organization:
Loyola University
Study Overview
Official Title:
A Randomized Controlled Phase III Adjuvant Trial of High-Dose Bolus IL-2 in Patients With High-Risk Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2017-01
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 purpose of this study is to assess the efficacy of post-operative high-dose bolus interleukin-2 IL-2 in patients with high-risk renal cell carcinoma RCC
Detailed Description:
The primary objective of this prospective randomized controlled trial is to compare the disease-free and overall survival of patients with stage III or IV high-risk renal cell carcinoma RCC who were treated with adjuvant high-dose interleukin-2 vs observation alone
Patients are stratified according to their disease classification and randomized to one course of IL-2 600000 Ukg every 8 hours on days 1 to 5 and days 15 to 19 maximum 28 doses or observation
Patients are stratified according to their disease classification and randomized to one course of IL-2 600000 Ukg every 8 hours on days 1 to 5 and days 15 to 19 maximum 28 doses or observation
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