Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-29 @ 9:03 AM
Study NCT ID:
NCT00659568
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2008-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metformin and Temsirolimus in Treating Patients With Metastatic or Unresectable Solid Tumor or Lymphoma
Sponsor:
London Health Sciences Centre
Organization:
Study Overview
Official Title:
A Phase I Study of Temsirolimus in Combination With Metformin in Advanced Solid Tumours
Status:
COMPLETED
Status Verified Date:
2010-08
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:
RATIONALE: Metformin and temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of metformin when given together with temsirolimus in treating patients with metastatic or unresectable solid tumor or lymphoma.
PURPOSE: This phase I trial is studying the side effects and best dose of metformin when given together with temsirolimus in treating patients with metastatic or unresectable solid tumor or lymphoma.
Detailed Description:
OBJECTIVES:
Primary
* To establish the maximum tolerated dose and recommended phase II dose of metformin hydrochloride when administered with temsirolimus in patients with advanced solid cancers or lymphoma.
Secondary
* To determine the toxicity and safety, with particular reference to glucose and lipid deregulation, of this regimen in these patients.
* To assess antitumor activity, including tumor response rate and time to progression, in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of metformin hydrochloride.
Patients receive oral metformin once, twice, or three times daily on days 1-28 and temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
Primary
* To establish the maximum tolerated dose and recommended phase II dose of metformin hydrochloride when administered with temsirolimus in patients with advanced solid cancers or lymphoma.
Secondary
* To determine the toxicity and safety, with particular reference to glucose and lipid deregulation, of this regimen in these patients.
* To assess antitumor activity, including tumor response rate and time to progression, in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of metformin hydrochloride.
Patients receive oral metformin once, twice, or three times daily on days 1-28 and temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
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?: