Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109967
Status:
COMPLETED
Last Update Posted:
2014-04-17
First Post:
2005-05-03
Brief Title:
CCI-779 and Rituximab in Treating Patients With Relapsed or Refractory 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 Combination With Rituximab in Patients With Relapsed or Refractory Mantle Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2013-12
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:
This phase II trial is studying how well giving CCI-779 together with rituximab works in treating patients with relapsed or refractory mantle cell lymphoma Drugs used in chemotherapy such as CCI-779 work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Monoclonal antibodies such as rituximab can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or carry cancer-killing substances to them Giving CCI-779 together with rituximab may kill more cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the overall response rate in patients with relapsed or refractory mantle cell lymphoma treated with CCI-779 and rituximab
II Determine the tolerability of this regimen in these patients by assessing toxicity
SECONDARY OBJECTIVES
I Determine the time to disease progression and overall survival of patients treated with this regimen
II Determine the duration of response in patients treated with this regimen
OUTLINE Patients are stratified according to prior response to rituximab sensitive partial response PR or complete response CR that lasted 6 months after the last treatment with rituximab alone or in combination with chemotherapy vs refractory stable or progressive disease OR a PR or CR that lasted 6 months after the last treatment with rituximab alone or in combination with chemotherapy
Patients receive CCI-779 IV over 30 minutes on days 1 8 15 and 22 Patients also receive rituximab IV on days 1 8 15 and 22 of course 1 and on day 1 only of courses 3 5 7 9 and 11 Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity After completion of course 3 patients undergo reevaluation Patients achieving a CR or an unconfirmed CR CRu receive 2 additional courses of treatment for a total of 5 courses Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment
After completion of study treatment 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 overall response rate in patients with relapsed or refractory mantle cell lymphoma treated with CCI-779 and rituximab
II Determine the tolerability of this regimen in these patients by assessing toxicity
SECONDARY OBJECTIVES
I Determine the time to disease progression and overall survival of patients treated with this regimen
II Determine the duration of response in patients treated with this regimen
OUTLINE Patients are stratified according to prior response to rituximab sensitive partial response PR or complete response CR that lasted 6 months after the last treatment with rituximab alone or in combination with chemotherapy vs refractory stable or progressive disease OR a PR or CR that lasted 6 months after the last treatment with rituximab alone or in combination with chemotherapy
Patients receive CCI-779 IV over 30 minutes on days 1 8 15 and 22 Patients also receive rituximab IV on days 1 8 15 and 22 of course 1 and on day 1 only of courses 3 5 7 9 and 11 Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity After completion of course 3 patients undergo reevaluation Patients achieving a CR or an unconfirmed CR CRu receive 2 additional courses of treatment for a total of 5 courses Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment
After completion of study treatment 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 |
|---|---|---|---|
| CDR0000425334 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA025224 |
| N038H | None | None | None |
| U10CA025224 | NIH | None | None |