Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022464
Status:
COMPLETED
Last Update Posted:
2015-06-08
First Post:
2001-08-10
Brief Title:
CCI-779 in Treating Patients With Metastatic Melanoma
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
A Phase II Study Of CCI-779 NSC 683864 In Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2015-06
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of CCI-779 in treating patients who have metastatic melanoma
PURPOSE Phase II trial to study the effectiveness of CCI-779 in treating patients who have metastatic melanoma
Detailed Description:
OBJECTIVES
Determine the anti-tumor activity of CCI-779 in terms of progression-free survival in patients with metastatic melanoma
Determine the toxic effects of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive CCI-779 IV over 30 minutes on day 1 Courses repeat every 7 days in the absence of disease progression or unacceptable toxicity
Patients are followed for survival
PROJECTED ACCRUAL Approximately 40-50 patients will be accrued for this study within 12 months
Determine the anti-tumor activity of CCI-779 in terms of progression-free survival in patients with metastatic melanoma
Determine the toxic effects of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive CCI-779 IV over 30 minutes on day 1 Courses repeat every 7 days in the absence of disease progression or unacceptable toxicity
Patients are followed for survival
PROJECTED ACCRUAL Approximately 40-50 patients will be accrued for this study within 12 months
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 |
|---|---|---|---|
| U01CA063265 | NIH | None | None |
| P30CA033572 | NIH | None | None |
| CHNMC-PHII-27 | None | None | None |
| CHNMC-IRB-99167 | None | None | None |
| NCI-29 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA033572 |