Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033267
Status:
COMPLETED
Last Update Posted:
2014-04-03
First Post:
2002-04-09
Brief Title:
CCI-779 in Treating Patients With Mantle Cell Non-Hodgkins Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of CCI-779 in Previously Treated Patients With Mantle Cell Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2012-12
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:
Phase II trial to study the effectiveness of CCI-779 in treating patients who have mantle cell non-Hodgkins lymphoma Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die
Detailed Description:
OBJECTIVES
I Determine the objective responses in patients with previously treated mantle cell non-Hodgkins lymphoma treated with CCI-779
II Determine the toxic effects of this drug in these patients III Determine whether this drug inhibits cell proliferation pathways in these patients
OUTLINE
Patients receive CCI-779 IV over 30 minutes on days 1 8 15 and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients with stable disease receive a maximum of 6 courses Patients with partial response receive a maximum of 12 courses Patients with complete response CR receive 2 additional courses beyond CR
Patients are followed every 3 months for 1 year every 4 months for 1 year every 6 months for 1 year and then annually for 2 years
I Determine the objective responses in patients with previously treated mantle cell non-Hodgkins lymphoma treated with CCI-779
II Determine the toxic effects of this drug in these patients III Determine whether this drug inhibits cell proliferation pathways in these patients
OUTLINE
Patients receive CCI-779 IV over 30 minutes on days 1 8 15 and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients with stable disease receive a maximum of 6 courses Patients with partial response receive a maximum of 12 courses Patients with complete response CR receive 2 additional courses beyond CR
Patients are followed every 3 months for 1 year every 4 months for 1 year every 6 months for 1 year and then annually for 2 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 |
|---|---|---|---|
| U10CA025224 | NIH | CTEP | httpsreporternihgovquickSearchU10CA025224 |
| NCI-2012-01870 | REGISTRY | None | None |
| NCCTG-N0186 | None | None | None |
| CDR0000069269 | None | None | None |
| N0186 | OTHER | None | None |
| N0186 | OTHER | None | None |