The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies for patients with thyroid cancer. The trials are investigating novel drug combinations; the effects of radioiodine; blood cell modification; biomarker-targeted therapies; and the effects of surgical intervention. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.
Phase I
Study Type: Phase I/Interventional/Single Group Assignment
Study Title: A Phase 1 Study of Dabrafenib in Combination With Lapatinib in BRAF Mutant Thyroid Cancer
Study Sponsor and Collaborators: National Cancer Institute
Purpose: To study the side effects and best dose of lapatinib ditosylate when given together with dabrafenib in treating patients with thyroid cancer that cannot be removed by surgery and has not responded to previous treatment
Primary Outcome Measures: Maximum tolerated dose of lapatinib ditosylate, in combination with the established dose of dabrafenib, defined as the highest dose at which not more than 1/6 of the patients experience dose limiting toxicity [Time Frame: First 42 days of treatment]
Principal Investigator: Eric Sherman, MD, Memorial Sloan Kettering Cancer Center; 646-888-4234, shermane@mskcc.org
ClinicalTrials.gov Identifier: NCT01947023
Study Type: Phase I/Interventional/Single Group Assignment
Study Title: Evaluation of Thyroid Stunning From a Diagnostic Dose of I-123
Study Sponsor and Collaborators: University of Colorado, Denver
Purpose: To study if the small dose of radioiodine that is used for the dosimetry study on patients with differentiated thyroid cancer may stun the cancer cells and make the thyroid cancer treatment less effective.
Primary Outcome Measures: Difference in uptake of I-123 in the thyroid remnant in the neck in the two imaging studies. [Time Frame: 11 days]
Principal Investigator: Jennifer Kwak, MD, University of Colorado, Denver; contact Michelle Carr, CCRP, 720-848-6137, michelle.I2.carr@ucdenver.edu
ClinicalTrials.gov Identifier: NCT02278198
Phase I/II
Study Type: Phase I/II/Interventional/Single Group Assignment
Study Title: Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing Human Thyroglobulin to People With Thyroglobulin Expressing Thyroid Cancer
Study Sponsor and Collaborators: National Cancer Institute, National Institutes of Health Clinical Center
Purpose: To study an experimental therapy for treating patient with metastatic thyroid cancer that involves taking white blood cells from the patient, growing them in the laboratory in large numbers, genetically modifying these specific cells with a type of virus (retrovirus) to attack only the tumor cells, and then giving the cells back to the patient. In this protocol, the patient’s white blood cells are being modified with a retrovirus that has the gene for antithyroglobulin incorporated.
Primary Outcome Measures: Determine a safe dose of administration and determine if this approach will result in an objective tumor regression. [Time Frame: Approximately 4 years]
Principal Investigator: James C. Yang, MD, National Cancer Institute; 301-496-1574, jamesyang@mail.nih.gov
ClinicalTrials.gov Identifier: NCT02390739
Phase II
Study Type: Phase II/Interventional/Crossover Assignment
Study Title: A Randomized Phase 2 Study of Single Agent Dabrafenib (BRAFi) vs. Combination Regimen Dabrafenib (BRAFi) and Trametinib (MEKi) in Patients With BRAF Mutated Thyroid Carcinoma
Study Sponsor and Collaborators: National Comprehensive Cancer Network, Ohio State University Comprehensive Cancer Center
Purpose: To study how well dabrafenib works with or without trametinib in treating patients with recurrent thyroid cancer.
Primary Outcome Measures: Overall objective response rate, defined as the proportion of patients who have a minor response, partial response, or complete response assessed according to RECIST. [Time Frame: up to 24 weeks]
Principal Investigator: Manisha Shah, MD, The Ohio State University Comprehensive Cancer Center; 614-293-4680, manisha.shah@osumc.edu
ClinicalTrials.gov Identifier: NCT01723202
Study Type: Phase II/Interventional/Parallel Assignment
Study Title: Central Neck Dissection in Patients With Clinical Node Negative Thyroid Cancer
Study Sponsor and Collaborators: University of Wisconsin (Madison), National Cancer Institute, National Institutes of Health
Purpose: To study how well thyroid gland removal with or without central lymph node dissection works in treating patients with thyroid cancer or suspected thyroid cancer that has not spread to the lymph nodes.
Primary Outcome Measures: Postoperative serum calcium level, postoperative PTH, total calcium consumption, average episodes of hypocalcemia (and symptom severity), and requirement for calcium/calcitriol [Time Frame: varies; see clinicaltrials.gov for more information]
Principal Investigator: Rebecca Sippel, MD, University of Wisconsin Hospital and Clinics; sippel@surgery.wisc.edu
ClinicalTrials.gov Identifier: NCT02138214
Study Type: Phase II/Interventional/Single Group Assignment
Study Title: A Phase 2 Study of Trametinib in Combination With Radioiodine (RAI) for RAS Mutant or RAS/RAF Wild-Type, RAI-Refractory Recurrent and/or Metastatic Thyroid Cancers
Study Sponsor and Collaborators: National Cancer Institute
Purpose: To study how well trametinib works in increasing tumoral iodine incorporation in patients with thyroid cancer that has come back or spread to another place in the body.
Primary Outcome Measures: Iodine incorporation in thyroid cancer metastases to a predicted lesional absorbed radiation dose equal to or exceeding 2,000 cGy with the administration of =< 300 mCi RAI (Cohort B), Progression free survival (Cohort A), Proportion of patients alive following treatment with trametinib and I-124 (Cohort A) [Time Frame: At 6 months]
Principal Investigator: Alan Ho, MD, Memorial Sloan Kettering Cancer Center; 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.
