Thyroid Neoplasms Clinical Trial
Official title:
Phase II Trial of REVLIMID® (Lenalidomide) for Therapy of Radioiodine-Unresponsive Papillary & Follicular Thyroid Carcinomas
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00537095 -
Efficacy and Safety of Vandetanib (ZD6474) in Patients With Metastatic Papillary or Follicular Thyroid Cancer
|
Phase 2 | |
| Recruiting |
NCT04139096 -
Genetic Susceptibility to Radiation Induced Thyroid Cancer
|
||
| Completed |
NCT00754182 -
Subcuticular Suture Versus Synthetic Glue in Thyroidectomy Incision
|
N/A | |
| Completed |
NCT00094055 -
Study of the Anti-angiogenesis Agent AG-013736 in Patients With Metastatic Thyroid Cancer
|
Phase 2 | |
| Completed |
NCT00148213 -
Clinical Evaluation of a New Highly Sensitive Thyroglobulin Assay in Differentiated Thyroid Carcinoma
|
N/A | |
| Recruiting |
NCT06398795 -
Dual-port Trans-subclavian Thyroid Endoscopic Surgery
|
N/A | |
| Recruiting |
NCT01005654 -
Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms
|
||
| Active, not recruiting |
NCT05579782 -
Assessing Benefits of NIRAF Detection for Identifying Parathyroid Glands During Total Thyroidectomy
|
N/A | |
| Completed |
NCT01437254 -
To Compare Safety and the General Imaging Pattern of Cyclotron Produced Technetium vs. Generator Produced Technetium in Patients With Thyroid Cancer
|
Phase 1 | |
| Recruiting |
NCT03160274 -
Genetic Analysis of Pheochromocytomas, Paragangliomas and Associated Conditions
|
||
| Completed |
NCT00984282 -
Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer
|
Phase 3 | |
| Completed |
NCT01292044 -
The Role of Elastography in the Diagnosis of Thyroid Nodules
|
N/A | |
| Terminated |
NCT04644315 -
A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors
|
Phase 2 | |
| Active, not recruiting |
NCT02418247 -
Minimize Radioactive Iodine Ablation Of Remnant Thyroid in Differentiated Thyroid Cancer
|
Phase 2/Phase 3 | |
| Completed |
NCT00467506 -
Phase II Two-step Radioimmunotherapy Clinical Study in Medullary Thyroid Carcinoma
|
Phase 2 | |
| Completed |
NCT02430714 -
Post-marketing Surveillance of Lenvatinib Mesylate (Lenvima Capsule) in Patients With Unresectable Thyroid Cancer (Study LEN01T)
|
||
| Recruiting |
NCT04396912 -
Post-thyroidectomy Vocal Cord Paralysis Along With Hypocalcemia: STROBE - Guided Prospective Cohort
|
||
| Enrolling by invitation |
NCT04411290 -
Malignancy Predictors, Bethesda and TI-RADS Scores Correlated With Final Histopathology in Thyroid Diseases
|
||
| Recruiting |
NCT04410601 -
Post-thyroidectomy Dysphagia: An International Multicentric CONSORT - Compatible RCT
|
N/A | |
| Completed |
NCT03469310 -
Minimizing Narcotic Analgesics After Endocrine Surgery
|
Phase 4 |