Several important studies are underway for the investigation of various treatments for thyroid cancers.  Below is a list of active clinical trials in which ITOG members are participating.

 

Randomized Double-Blind Phase II Study of Radioactive Iodine (RAI) in Combination with Placebo or Selumetinib for the Treatment of RAI-Avid Recurrent/Metastatic Thyroid Cancers (Actively Recruiting) 

       Principal Investigator – Alan Ho, MD, PhD, Memorial Sloan-Kettering Cancer Center

       Email: hoa@mskcc.org

This is a randomized Phase II trial evaluating the effectiveness of selumetinib compared to placebo to enhance uptake of radioactive iodine (RAI) in patients with RAI-avid, recurrent or metastatic thyroid cancer of follicular cell origin. Radioiodine is a key therapy for patients with metastatic thyroid cancer, yet many patients have tumors that do not adequately concentrate RAI, leading to diminished clinical efficacy. Studies indicate that abnormal mitogen-activated protein kinase (MAPK) activation suppresses RAI uptake in thyroid cancers, a process that can be reversed with drugs, such as selumetinib, which selectively inhibit this pathway. In this study, we will test whether administration of selumetinib in conjunction with RAI treatment can increase absorption of RAI, thus providing a more effective way to treat these cancers.

Eligible patients must have confirmed RAI-avid, progressive thyroid carcinoma of follicular origin, including papillary, follicular, or poorly differentiated subtypes.

Patients who meet all eligibility criteria will be randomized to treatment with selumetinib versus placebo prior to RAI. Tumor and blood samples will also be analyzed for markers that may predict which patients could benefit from this strategy as well as provide information on how MAPK signaling contributes to RAI resistance. More information related to this trial is available at https://clinicaltrials.gov/show/NCT02393690.

Participating sites

Selumetinib plus RAI in RAI-avid DTC
Site Principal Investigator Site Institution Site Location
Ken Burman, MD MedStar Washington Hospital Center Washington, DC
Gregory Daniels, MD, PhD University of California San Diego Moores Cancer Center       La Jolla, CA
Ramona Dadu, MD MD Anderson Cancer Center Houston, TX
Bryan Haugen, MD University of Colorado Aurora, CO
Alan Ho, MD, PhD (Study PI)      Memorial Sloan Kettering Cancer Center       New York, NY
Mabel Ryder, MD Mayo Clinic - Rochester Rochester, MN      
Jennifer Sipos, MD Ohio State University Comprehensive Cancer Center          Columbus, OH
Jill Daniels, MD Vanderbilt University/Ingram Cancer Center Nashville, TN
Lori Wirth, MD Massachusetts General Hospital Boston, MA
Michael Demeure, MD Hoag Memorial Hospital Newport Beach, CA  

 

ACCRU/ITOG 1504 Combination Immunotherapy with Multikinase Inhibitor (MKI) in Progressive, Radioiodine-resistant Differentiated Thyroid Cancers  (Actively Recruiting)

      Principal Investigator -- Bryan Haugen, MD, University of Colorado Medical Center

      Email:  bryan.haugen@ucdenver.edu

This is a phase II trial to examine the effficacy of pembrolizumab and lenvatinib in combination to treat progressive thyroid cancer which cannot be surgically removed.  Pembrolizumab is a monoclonal antibody that stimulates the immune system to attack the thyroid cancer.  Lenvatinib, a kinase inhibitor, acts by inhibiting cell growth and the tumor's ability to spread. 

Eligibility criteria include patients aged 18 years and older with locally recurrent, iodine refractory, progressive and unresectable, and/or distant metastatic differentiated thyroid cancer (DTC) with measurable disease.  Measurable disease is defined as having at least one lesion measuring >= 1.0cm in the longest diameter for a non-lymph node or >=1.5cm in the short-axis diameter for a lymph node. Radioiodine (RAI) refractory disease is defined as one or more of the following criteria: one or more measurable lesions that do not demonstrate RAI uptake, one or more measurable lesions progressive by RECIST 1.1 =< 14 months of prior RAI, one or more measurable lesions after cumulative RAI dose of >=600mCi, or one or more measurable lesions that are PET-18FDG avid.   Progressive disease is defined as evidence of tumor growth as measured by RECIST 1.1 within =< 14 months prior to registration or progressive disease on lenvatinib per RECIST 1.1 =<30 days prior to registration. Differentiated thyroid cancers include the following subtypes: papillary thyroid cancer (PTC) (including but not limited to variants such as follicular variant, tall cell, columnar cell, Hurthle cell variant of PTC, and poorly differentiated), follicular thyroid cancer, including insular variant, Hurthle cell carcinoma, and poorly differentiated thyroid cancer.

Patients who are eligible for this study will be administered oral lenvatinib on days 1-21 and pembrolizumab IV over 30 minutes on day 1.  Treatment repeats every 21 days for up to 19 courses in the absence of disease progression or unacceptable toxicity.  Patients may continue treatment for up to 35 courses if a disease response is demonstrated.  More information for this trial is available at clinical trials.gov.

Participating sites

ACCRU/ITOG 1504 Combination Immunotherapy with Multikinase Inhibitor (MKI) in Progressive, Radioiodine-resistant Differentiated Thyroid Cancers

Site Principal Investigator Site Institution Site Location
Gregory A. Daniels, MD, PhD UC San Diego Moores Cancer Center La Jolla, CA
Alexander D. Colevas, MD Standfor Cancer Institute Palo Alto Palo Alto, CA
Andrew G. Gianoukakis, MD Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center Torrence, CA
Daniel W. Bowles, MD University of Colorado Hospital Aurora, CO
Lori J. Wirth, MD Massachusetts General Hospital Cancer Center  Boston, MA
Frances P. Worden, MD University of Michigan Comprehensive Cancer Center Ann Ann Arbor, MI
Eric J. Sherman, MD Memorial Sloan Kettering Cancer Center New York, NY
Bhavana Konda, MD, MPH Ohio State University Comprehensive Cancer Center Columbus, OH
Jill Gilbert, MD Vanderbilt University/Ingram Cancer Center Nashville, TN
Ramona Dadu, MD MD Anderson Cancer Center Houston, TX