Conditions: Thyroid Neoplasms
Keywords: Lenalidomide Clinical Trials phase II Carcinomas, thyroid Radioiodine-Unresponsive Papillary Follicular
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 25
Healthy volunteers: no

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.

Arms:
arm 1: Treatment will be initated at 25 mg/day taken in the morning. Dose adjustments may be made to alleviate toxicities.

Interventions: intervention 1: Lenalidomide
Intervention descriptions: intervention 1: Initial dose is 25 mg/day dose will be adjusted accordingly as needed. Dose range for the study is 5 to 25 mg/day

Protocol document:
Prot_SAP_000.pdf: 
PROTOCOL AND STATISTICAL ANALYSIS PLAN 
 
 Study Title: REVLIMID (Lenalidomide) for Therapy of Radioiodine-Unresponsive Papillary and 
Follicular Thyroid Carcinoma 
Institution/Site:  
University of Kentucky 
Document (Approval/Update) Date: 
09-21-2008 
NCT Number: 
NCT00287287 
IRB Number 
05-701-F3R 
Coversheet created: 
05-28-2020