Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00079456
Status:
COMPLETED
Last Update Posted:
2013-10-11
First Post:
2004-03-08
Brief Title:
Temsirolimus in Treating Patients With Relapsed or Refractory Multiple Myeloma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of CCI-779 in Patients With Relapsed or Refractory Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2013-10
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 temsirolimus works in treating patients with relapsed or refractory multiple myeloma Drugs used in chemotherapy such as temsirolimus work in different ways to stop cancer cells from dividing so they stop growing or die
Detailed Description:
PRIMARY OBJECTIVES
I Determine the overall response rate in patients with relapsed or refractory multiple myeloma treated with CCI-779
SECONDARY OBJECTIVES
I Determine the progression-free survival of patients treated with this drug II Determine the toxicity of this drug in these patients III Determine the presence of PTEN mutation in patients treated with this drug
IV Correlate the pharmacokinetics of this drug with response in these patients
V Correlate the pharmacodynamic effects of this drug with response in these patients
OUTLINE This is an open-label study
Patients receive temsirolimus IV over 30 minutes on days 1 8 15 and 21 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
I Determine the overall response rate in patients with relapsed or refractory multiple myeloma treated with CCI-779
SECONDARY OBJECTIVES
I Determine the progression-free survival of patients treated with this drug II Determine the toxicity of this drug in these patients III Determine the presence of PTEN mutation in patients treated with this drug
IV Correlate the pharmacokinetics of this drug with response in these patients
V Correlate the pharmacodynamic effects of this drug with response in these patients
OUTLINE This is an open-label study
Patients receive temsirolimus IV over 30 minutes on days 1 8 15 and 21 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
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 |
|---|---|---|---|
| N01CM62207 | NIH | CTEP | httpsreporternihgovquickSearchN01CM62207 |
| NCI-2012-01448 | REGISTRY | None | None |
| NCI-6186 | None | None | None |
| OSU-0347 | None | None | None |
| CDR0000355767 | None | None | None |
| OSU-2003C0090 | None | None | None |
| 0347 | OTHER | None | None |
| 6186 | OTHER | None | None |
| R21CA112894 | NIH | None | None |