The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on targeted therapy in thyroid cancer. These trials are studying immunosuppressants, combination therapies, tyrosine kinase inhibitor treatment, mitigation of treatment side effects, immunotherapy, and more. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.
Study Title: UPCC 36315: A Phase II Study of Everolimus (RAD001) and Lenvatinib (E7080) in Patients With Metastatic Differentiated Thyroid Cancer Who Have Progressed on Lenvatinib Alone
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: Abramson Cancer Center of the University of Pennsylvania
Purpose: To study the combination of everolimus and lenvatinib in patients with metastatic differentiated thyroid cancer whose disease has progressed on lenvatinib alone
Primary Outcome Measures: Number of subjects with progression-free survival [time frame: 2 years]
Principal Investigator: Marcia Brose, MD, PhD; (855) 216-0098, penncancertrials@emergingmed.com
ClinicalTrials.gov Identifier: NCT03139747
Study Title: An Open-Label Phase II Trial Evaluating the Efficacy of Cyclophosphamide and Sirolimus for the Treatment of Metastatic, Radioactive Iodine–Refractory, Differentiated Thyroid Cancer
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: University of Michigan Cancer Center
Purpose: To evaluate the combination of cyclophosphamide and sirolimus for the treatment of metastatic differentiated thyroid cancer in a nonrandomized pilot trial setting
Primary Outcome Measures: Percentage of patients who respond to treatment [time frame: patients will be followed for response until disease progression or up to 2 years]
Principal Investigator: Francis Worden, MD; (734) 936-0453, fworden@umich.edu
ClinicalTrials.gov Identifier: NCT03099356
Study Title: Adaptive Tyrosine Kinase Inhibitor Therapy in Patients With Advanced Progressive Thyroid Cancer
Study Type: Interventional/randomized/parallel assignment
Study Sponsor and Collaborators: H. Lee Moffitt Cancer Center and Research Institute
Purpose: To evaluate the efficacy and tolerability of tyrosine kinase inhibitor therapy (lenvatinib or sorafenib for differentiated thyroid cancer [which includes papillary thyroid cancer, follicular thyroid cancer, and poorly differentiated thyroid cancer]; and cabozantinib or vandetanib for medullary thyroid cancer) through adaptive (intermittent) vs conventional (continuous) regimen
Primary Outcome Measures: Time to tyrosine kinase inhibitor treatment discontinuation due to progressive disease, intolerability, or disease-related death [time frame: 2 years]
Principal Investigator: Christine H. Chung, MD; (813) 745-5061, christine.chung@moffitt.org
ClinicalTrials.gov Identifier: NCT03630120
Study Title: Pilot Study of Metformin to Mitigate Sequelae of Radioactive Iodine Treatment for Well-Differentiated Thyroid Cancers
Study Type: Interventional/randomized/parallel assignment
Study Sponsor and Collaborators: Sidney Kimmel Cancer Center at Thomas Jefferson University
Purpose: To study how well metformin hydrochloride works in mitigating the side effects of radioactive iodine treatment in patients with differentiated thyroid cancer
Primary Outcome Measures: Complete blood cell count, serum and salivary exosome profile, and incidence of adverse events assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [time frame: up to 36 months of study duration]
Principal Investigator: Joseph Curry, MD; (215) 955-6760
ClinicalTrials.gov Identifier: NCT03109847
Study Title: Phase II Trial of Pembrolizumab in Recurrent or Metastatic Medullary Thyroid Cancer
Study Type: Interventional/nonrandomized/parallel assignment
Study Sponsor and Collaborators: National Cancer Institute (NCI), National Institutes of Health Clinical Center
Purpose: To determine whether administering a programmed cell death protein 1 (PD-1) inhibitor to patients with medullary thyroid cancer will permit a modest fraction to be able to experience a 50% or greater decline in calcitonin levels or experience a partial or complete response on imaging
Primary Outcome Measures: Determine whether a PD-1 inhibitor will permit a decline in calcitonin levels or response on imaging in patients with medullary thyroid cancer [time frame: 1 year]
Principal Investigator: Ravi A. Madan, MD, National Cancer Institute; contact Myrna Rauckhorst, RN, (240) 760-6069, mrauckhorst@mail.nih.gov
ClinicalTrials.gov Identifier: NCT03072160
Study Title: A Phase II Study of Trametinib in Combination With Radioactive Iodine for RAS-Mutant or RAS/RAF Wild-Type, Radioactive Iodine–Refractory Recurrent and/or Metastatic Thyroid Cancers
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: NCI
Purpose: To study how well trametinib works in increasing tumoral iodine incorporation in patients with recurrent or metastatic thyroid cancer
Primary Outcome Measures: Proportion of patients alive following treatment with trametinib and iodine-124 (cohort A) [time frame: at 6 months]
Principal Investigator: Alan Ho, MD, PhD; (646) 888-4235, hoa@mskcc.org
ClinicalTrials.gov Identifier: NCT02152995
Editor’s Note: The clinical trials presented here do not represent all the trials listed on ClinicalTrials.gov. For the complete list, go to ClinicalTrials.gov. ■
