Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00422656
Status:
COMPLETED
Last Update Posted:
2017-12-26
First Post:
2007-01-12
Brief Title:
Perifosine in Patients With RelapsedRefractory Waldenstroms Macroglobulinemia
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Study of Perifosine in Patients With RelapsedRefractory Waldenstroms Macroglobulinemia
Status:
COMPLETED
Status Verified Date:
2017-11
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:
Waldenströms Macroglobulinemia lymphoplasmacytic lymphoma WM remains incurable with limited therapeutic options and notably absent FDA approved therapy with any WM indication Therefore there is a need to identify new therapeutic agents for WM patients both in the upfront and relapsedrefractory setting The purpose of this research study is to assess the efficacy of perifosine in patients with relapsed or refractory WM
Detailed Description:
Perifosine is a drug that in particular inhibits Akt thought to be important for initiation and progression of malignancies specifically in lymphomas In laboratory experiments of WM and lymphoma cell lines perifosine has shown to have cytotoxic and anti-proliferative activity as a single agent This drug has been used in clinical research studies of other types of cancers including soft tissue sarcomas head and neck cancers and prostate cancer This study uses a two-stage design to evaluate efficacy of perifosine based on overall response OR The null and alternative OR rates are 20 and 40 If 4 or more patients enrolled in the stage one cohort n17 patients achieve OR than accrual will proceed to stage two n20 patients If fewer than 10 ORs are observed then the regimen will be considered ineffective
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