Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087022
Status:
COMPLETED
Last Update Posted:
2018-11-27
First Post:
2004-07-08
Brief Title:
Monoclonal Antibody Therapy Rencarex in Treating Patients Who Have Undergone Surgery for Non-metastatic Kidney Cancer
Sponsor:
Heidelberg Pharma AG
Organization:
Heidelberg Pharma AG
Study Overview
Official Title:
A Randomized Double Blind Phase III Study To Evaluate Adjuvant cG250 Treatment Versus Placebo In Patients With Clear Cell RCC And High Risk of Recurrence ARISER
Status:
COMPLETED
Status Verified Date:
2018-10
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:
RATIONALE Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells It is not yet known whether monoclonal antibody therapy is effective in treating kidney cancer
PURPOSE This randomized phase III trial is studying monoclonal antibody therapy to see how well it works in treating patients who have undergone surgery for nonmetastatic primary kidney cancer
PURPOSE This randomized phase III trial is studying monoclonal antibody therapy to see how well it works in treating patients who have undergone surgery for nonmetastatic primary kidney cancer
Detailed Description:
OBJECTIVES
Primary
Evaluate the disease-free and overall survival of patients with primary clear cell renal cell carcinoma at high risk for recurrence treated with chimeric monoclonal antibody cG250 WX-G250 vs placebo in an adjuvant setting
Secondary
Evaluate the safety of these drugs in these patients
Assess the quality of life of patients treated with this drug
Perform pharmacokinetic analysis of WX-G250
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to risk criteria and participating centers US vs Non-US Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive monoclonal chimeric antibody cG250 WX-G250 IV over 15 minutes once weekly for 24 weeks
Arm II Patients receive placebo IV over 15 minutes once weekly for 24 weeks In both arms treatment continues in the absence of disease progression or unacceptable toxicity
Blood samples are collected for pharmacokinetic analysis
Quality of life is assessed at baseline at weeks 12 and 24 during treatment and then at 6 months after completion of study treatment
Patients are followed every 3 months during years 1 and 2 every 6 months during years 3 and 4 and then annually during year 5 and thereafter
PROJECTED ACCRUAL A total of 864 patients out of the expected 856 428 per treatment arm were accrued for this trial
Primary
Evaluate the disease-free and overall survival of patients with primary clear cell renal cell carcinoma at high risk for recurrence treated with chimeric monoclonal antibody cG250 WX-G250 vs placebo in an adjuvant setting
Secondary
Evaluate the safety of these drugs in these patients
Assess the quality of life of patients treated with this drug
Perform pharmacokinetic analysis of WX-G250
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to risk criteria and participating centers US vs Non-US Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive monoclonal chimeric antibody cG250 WX-G250 IV over 15 minutes once weekly for 24 weeks
Arm II Patients receive placebo IV over 15 minutes once weekly for 24 weeks In both arms treatment continues in the absence of disease progression or unacceptable toxicity
Blood samples are collected for pharmacokinetic analysis
Quality of life is assessed at baseline at weeks 12 and 24 during treatment and then at 6 months after completion of study treatment
Patients are followed every 3 months during years 1 and 2 every 6 months during years 3 and 4 and then annually during year 5 and thereafter
PROJECTED ACCRUAL A total of 864 patients out of the expected 856 428 per treatment arm were accrued for this trial
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-00491 | REGISTRY | CTRP Clinical Trials Reporting System | None |
| WILEX-WX-2003-07-HR | OTHER | None | None |
| ARISER | OTHER | None | None |
| UCLA-0404015-01 | OTHER | None | None |
| CDR0000372830 | REGISTRY | None | None |