Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00290472
Status:
COMPLETED
Last Update Posted:
2014-05-23
First Post:
2006-02-10
Brief Title:
CCI-779 in Treating Patients With Recurrent or Refractory B-Cell Non-Hodgkins Lymphoma or Chronic Lymphocytic Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of CCI-779 in B-cell Lymphoma and CLL
Status:
COMPLETED
Status Verified Date:
2013-02
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:
Drugs used in chemotherapy such as CCI-779 work in different ways to stop cancer cells from dividing so they stop growing or die This phase II trial is studying how well CCI-779 works in treating patients with recurrent or refractory B-cell non-Hodgkins lymphoma or chronic lymphocytic leukemia
Detailed Description:
PRIMARY OBJECTIVES
I Determine the complete and partial response rate in patients with recurrent or refractory B-cell non-Hodgkins lymphoma or chronic lymphocytic leukemia treated with CCI-779
II Determine the toxicity and safety of this drug in these patients III Correlate the degree of activation of P13AKTmTOR pathway and levels of CDK inhibitors with response in patients treated with this drug
IV Correlate CCI-779 induced inactivation of mTOR with response in these patients
OUTLINE Patients are stratified according to disease aggressive lymphoma group A vs follicular lymphoma group B vs small lymphocytic lymphoma or chronic lymphocytic leukemia group C
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 are followed every 8 weeks
I Determine the complete and partial response rate in patients with recurrent or refractory B-cell non-Hodgkins lymphoma or chronic lymphocytic leukemia treated with CCI-779
II Determine the toxicity and safety of this drug in these patients III Correlate the degree of activation of P13AKTmTOR pathway and levels of CDK inhibitors with response in patients treated with this drug
IV Correlate CCI-779 induced inactivation of mTOR with response in these patients
OUTLINE Patients are stratified according to disease aggressive lymphoma group A vs follicular lymphoma group B vs small lymphocytic lymphoma or chronic lymphocytic leukemia group C
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 are followed every 8 weeks
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 |
|---|---|---|---|
| P30CA014599 | NIH | CTEP | httpsreporternihgovquickSearchP30CA014599 |
| NCI-2009-00047 | REGISTRY | None | None |
| CDR0000365314 | None | None | None |
| NCI-6199 | None | None | None |
| 12983A | None | None | None |
| 6199 | OTHER | None | None |
| 6199 | OTHER | None | None |
| N01CM62201 | NIH | None | None |
| N01CM62202 | NIH | None | None |