Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00287287
Status:
COMPLETED
Last Update Posted:
2020-06-12
First Post:
2006-02-03
Brief Title:
REVLIMID Lenalidomide for Therapy of Radioiodine-Unresponsive Papillary and Follicular Thyroid Carcinomas
Sponsor:
Kenneth Ain
Organization:
University of Kentucky
Study Overview
Official Title:
Phase II Trial of REVLIMID Lenalidomide for Therapy of Radioiodine-Unresponsive Papillary Follicular Thyroid Carcinomas
Status:
COMPLETED
Status Verified Date:
2020-05
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:
The primary objective of the study is to assess the anti-tumor activity of REVLIMID lenalidomide administered as a single agent in patients with distantly metastatic thyroid carcinomas which are unresponsive to systemic radioiodine in terms of tumor response and response duration
Detailed Description:
Thalidomide has found new uses as a tumor anti-angiogenesis agent that is capable of diminishing the proliferation of angiogenesis-dependent solid malignancies Distantly metastatic unresectable medullary thyroid carcinomas as well as de-differentiated papillary and follicular thyroid carcinomas which no longer concentrate radioiodine have no known effective systemic therapies We have verified in the context of a completed phase 2 clinical trial that thalidomide has significant activity in thyroid carcinomas that are no longer radioiodine avid and are rapidly progressive This activity has only limited durability of around 7 months and is associated with significant toxicities of sedation constipation and neuropathy
REVLIMID lenalidomide is an analog of thalidomide with the chemical name alpha-3-aminophthalimido glutarimide REVLIMID is noted to be more potent than thalidomide in inhibiting the production of TNF-alpha It has more than doubled the inhibition of microvessel growth at the same concentration as thalidomide in a rat aorta angiogenesis model as well as greatly enhanced activity as an IMiD Most importantly it lacks much of the toxicity of thalidomide particularly in regards to somnolence neuropathy or biochemical effects In fact patients with multiple myeloma known to be resistant to thalidomide were still seen to exhibit clinical responses to REVLIMID This makes REVLIMID an appropriate agent to investigate in a phase 2 trial in thyroid carcinoma
REVLIMID lenalidomide is an analog of thalidomide with the chemical name alpha-3-aminophthalimido glutarimide REVLIMID is noted to be more potent than thalidomide in inhibiting the production of TNF-alpha It has more than doubled the inhibition of microvessel growth at the same concentration as thalidomide in a rat aorta angiogenesis model as well as greatly enhanced activity as an IMiD Most importantly it lacks much of the toxicity of thalidomide particularly in regards to somnolence neuropathy or biochemical effects In fact patients with multiple myeloma known to be resistant to thalidomide were still seen to exhibit clinical responses to REVLIMID This makes REVLIMID an appropriate agent to investigate in a phase 2 trial in thyroid carcinoma
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None