Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-02 @ 5:02 PM
Study NCT ID:
NCT00079456
Status:
COMPLETED
Last Update Posted:
2013-10-11
First Post:
2004-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Temsirolimus in Treating Patients With Relapsed or Refractory Multiple Myeloma
Sponsor:
National Cancer Institute (NCI)
Organization:
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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2012-01448 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| NCI-6186 | None | None | View | |
| OSU-0347 | None | None | View | |
| CDR0000355767 | None | None | View | |
| OSU-2003C0090 | None | None | View | |
| 0347 | OTHER | Ohio State University Medical Center | View | |
| 6186 | OTHER | CTEP | View | |
| R21CA112894 | NIH | None | https://reporter.nih.gov/quic… | View |
| N01CM62207 | NIH | None | https://reporter.nih.gov/quic… | View |