Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00433446
Status:
COMPLETED
Last Update Posted:
2013-02-05
First Post:
2007-02-08
Brief Title:
S0354 Anti-IL-6 Chimeric Monoclonal Antibody in Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
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 Hormone Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2013-01
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:
RATIONALE Monoclonal antibodies such as anti-IL-6 chimeric monoclonal antibody 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 anti-IL-6 chimeric monoclonal antibody works in treating patients with metastatic prostate cancer that did not respond to hormone therapy
PURPOSE This phase II trial is studying how well anti-IL-6 chimeric monoclonal antibody works in treating patients with metastatic prostate cancer that did not respond to hormone therapy
Detailed Description:
OBJECTIVES
Primary
Assess the confirmed prostate-specific antigen response in patients with hormone-refractory metastatic prostate cancer treated with anti-IL-6 chimeric monoclonal antibody
Secondary
Assess overall survival and progression-free survival of these patients
Assess the objective response rate confirmed and unconfirmed complete and partial response in patients with measurable disease treated with this regimen
Assess the qualitative and quantitative toxicities of this regimen
OUTLINE This is an open-label multicenter study
Patients receive anti-IL-6 chimeric monoclonal antibody IV over 2 hours on day 1 Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 1 year and then every 6 months for up to 2 years
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
Primary
Assess the confirmed prostate-specific antigen response in patients with hormone-refractory metastatic prostate cancer treated with anti-IL-6 chimeric monoclonal antibody
Secondary
Assess overall survival and progression-free survival of these patients
Assess the objective response rate confirmed and unconfirmed complete and partial response in patients with measurable disease treated with this regimen
Assess the qualitative and quantitative toxicities of this regimen
OUTLINE This is an open-label multicenter study
Patients receive anti-IL-6 chimeric monoclonal antibody IV over 2 hours on day 1 Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 1 year and then every 6 months for up to 2 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 | None | None |
| S0354 | OTHER | SWOG | httpsreporternihgovquickSearchU10CA032102 |