Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00057889
Status:
COMPLETED
Last Update Posted:
2012-03-15
First Post:
2003-04-07
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Metastatic Renal Cell Cancer
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase II Open-Label Study of Single Agent MDX-010 for the Treatment of IL-2 Refractory or IL-2 Ineligible Patients With Stage IV Renal Cancer
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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
PURPOSE Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have metastatic renal cell cancer kidney cancer that is refractory to treatment with interleukin-2 or unable to be treated with interleukin-2
PURPOSE Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have metastatic renal cell cancer kidney cancer that is refractory to treatment with interleukin-2 or unable to be treated with interleukin-2
Detailed Description:
OBJECTIVES
Determine the activity of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody in patients with metastatic clear cell renal cancer who are refractory to or ineligible for interleukin-2
Determine the impact of this drug on T-cell number and phenotype in these patients
OUTLINE This is an open-label study
Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody IV over 90 minutes once every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity Patients with an ongoing partial response may receive additional courses of therapy
Patients are followed at 4 weeks every 3 months for 1 year every 6 months for 2 years and then annually until disease progression
PROJECTED ACCRUAL A total of 21-103 patients will be accrued for this study within 2-4 years
Determine the activity of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody in patients with metastatic clear cell renal cancer who are refractory to or ineligible for interleukin-2
Determine the impact of this drug on T-cell number and phenotype in these patients
OUTLINE This is an open-label study
Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody IV over 90 minutes once every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity Patients with an ongoing partial response may receive additional courses of therapy
Patients are followed at 4 weeks every 3 months for 1 year every 6 months for 2 years and then annually until disease progression
PROJECTED ACCRUAL A total of 21-103 patients will be accrued for this study within 2-4 years
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 |
|---|---|---|---|
| CDR0000285624 | None | None | None |
| 03-C-0094 | None | None | None |