Ignite Creation Date:
2024-05-06 @ 12:40 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01637090
Status:
TERMINATED
Last Update Posted:
2017-01-12
First Post:
2012-04-02
Brief Title:
Everolimus in Treating Cutaneous T-cell Lymphoma
Sponsor:
Adam Lerner
Organization:
Boston Medical Center
Study Overview
Official Title:
PHASE II TRIAL OF THE mTOR INHIBITOR EVEROLIMUS IN RELAPSED OR REFRACTORY CUTANEOUS T-CELL LYMPHOMA CTCL
Status:
TERMINATED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CTCL
Brief Summary:
CTCL is a rare form of lymphoma of the skin While early stages are usually confined to the skin later stages may spread to blood lymph nodes and other organs At this point patients usually require systemic chemo This study will investigate the effect of everolimus as treatment for recurrent or refractory CTCL Participation in this study will last as long as the study doctor believes disease has not gotten worse and patients continue to tolerate the study medication for a maximum of 1 year Once off the treatment patients will be followed for two years
Detailed Description:
Cutaneous T-cell lymphoma is a rare form of lymphoma of the skin While early stages are usually confined to the skin later stages may spread to blood lymph nodes and other organs At this point patients usually require systemic chemotherapy This study will investigate the effect of everolimus as a treatment for patients diagnosed with CTCL that has either not responded to previous treatments or has recurred despite previous treatments Everolimus is the common name for the commercial drug Afinitor Novartis It is approved by the US Food and Drug Administration FDA for use in kidney and brain cancer In several different forms of lymphomas everolimus is used as an investigational drug which means it has not been approved by the FDA for this group of diseases
Everolimus blocks a protein mTOR that helps cells and tumors to grow Earlier studies have indicated that the drug everolimus may work against lymphomas including cutaneous T-cell lymphomas Participation in this study will last as long as the study doctor believes disease has not gotten worse and patients continue to tolerate the study medication for a maximum of 1 year Once off the treatment patients will be followed for two years
Everolimus blocks a protein mTOR that helps cells and tumors to grow Earlier studies have indicated that the drug everolimus may work against lymphomas including cutaneous T-cell lymphomas Participation in this study will last as long as the study doctor believes disease has not gotten worse and patients continue to tolerate the study medication for a maximum of 1 year Once off the treatment patients will be followed for two 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