Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00311545
Status:
WITHDRAWN
Last Update Posted:
2013-02-20
First Post:
2006-04-05
Brief Title:
S0351 CNTO 328 in Treating Patients With Unresectable or Metastatic Kidney Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Phase II Study of CNTO 328 A Monoclonal Antibody Against Interleukin-6 IL-6 In Patients With Advanced or Metastatic Renal Cell Cancer
Status:
WITHDRAWN
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
withdrawal of support for drug supply
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Monoclonal antibodies such as CNTO 328 can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them
PURPOSE This phase II trial is studying how well CNTO 328 works in treating patients with unresectable or metastatic kidney cancer
PURPOSE This phase II trial is studying how well CNTO 328 works in treating patients with unresectable or metastatic kidney cancer
Detailed Description:
OBJECTIVES
Primary
Assess the probability of response confirmed complete and partial responses in patients with unresectable or metastatic renal cell cancer treated with CNTO 328
Secondary
Assess the 6-month progression-free survival probability and median overall survival in these patients
Evaluate the qualitative and quantitative toxicities of this treatment
Investigate in a preliminary manner the association of tumor response with potential markers of anti-interleukin-6 activity
OUTLINE This is a multicenter study
Patients receive CNTO 328 IV over 2 hours on day 1 Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity Patients achieving complete or partial response after 6 courses of therapy may receive an additional 6 courses
After completion of study treatment patients are followed periodically for 3 years
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
Primary
Assess the probability of response confirmed complete and partial responses in patients with unresectable or metastatic renal cell cancer treated with CNTO 328
Secondary
Assess the 6-month progression-free survival probability and median overall survival in these patients
Evaluate the qualitative and quantitative toxicities of this treatment
Investigate in a preliminary manner the association of tumor response with potential markers of anti-interleukin-6 activity
OUTLINE This is a multicenter study
Patients receive CNTO 328 IV over 2 hours on day 1 Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity Patients achieving complete or partial response after 6 courses of therapy may receive an additional 6 courses
After completion of study treatment patients are followed periodically for 3 years
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S0351 | OTHER | None | None |