REVLIMID® (Lenalidomide) for Therapy of Radioiodine-Unresponsive Papillary and Follicular Thyroid Carcinomas
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|ClinicalTrials.gov Identifier: NCT00287287|
Recruitment Status : Completed
First Posted : February 6, 2006
Results First Posted : June 12, 2020
Last Update Posted : June 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Thyroid Neoplasms||Drug: Lenalidomide||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of REVLIMID® (Lenalidomide) for Therapy of Radioiodine-Unresponsive Papillary & Follicular Thyroid Carcinomas|
|Actual Study Start Date :||February 2006|
|Actual Primary Completion Date :||July 6, 2010|
|Actual Study Completion Date :||July 6, 2010|
Experimental: Lenalidomide (Revlimid)
Treatment will be initated at 25 mg/day taken in the morning. Dose adjustments may be made to alleviate toxicities.
Initial dose is 25 mg/day dose will be adjusted accordingly as needed. Dose range for the study is 5 to 25 mg/day
Other Name: Revlimid
- Response Rate [ Time Frame: 4 years ]Percentage of patients who responded to treatment (either stable disease or complete response) based on total tumor volume measurements from CT scans.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00287287
|United States, Kentucky|
|University of Kentucky Markey Cancer Center|
|Lexington, Kentucky, United States, 40536|
|Principal Investigator:||Kenneth B Ain, M.D.||University of Kentucky|