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)

 

       Primary 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

 

 

Selumetinib plus RAI in RAI-avid DTC

Site Primary Investigator

Site Institution

Site Location

Ken Burman, MD

MedStar Washington Hospital Center

Washington, DC

Ezra Cohen, MD

Greg Daniels, MD

University of California - San Diego

San Diego, CA

Ramona Dadu, MD

MD Anderson Cancer Center

Houston, TX

Bryan Haugen, MD

University of Colorado

Denver, CO

Alan Ho, MD, PhD (Study PI)

Memorial Sloan-Kettering Cancer Center

New York City, NY

Mabel Ryder, MD

Mayo Clinic - Rochester

Rochester, MN

Jennifer Sipos, MD

Ohio State University

Columbus, OH

Julie Ann Sosa, MD

Duke University Health System

Durham, NC

Lori Wirth, MD

Jochen Lorch, MD, MSc

Massachusetts General Hospital

Dana-Farber Cancer Institute

Boston, MA

 

An Open-Label, Single-Arm, Multicenter, Phase 2 Trial of Lenvatinib for the Treatment of Anaplastic Thyroid Cancer (ATC)     (Actively Recruiting)

 

Lead ITOG Investigator – Lori Wirth, MD, Massachusetts General Hospital

       Email: lwirth@mgh.harvard.edu

 

This is a single-arm Phase II trial investigating potential treatment for anaplastic thyroid cancer (ATC) with lenvatinib. While ATC is rare, it is one of the most aggressive solid tumors. Treatment of ATC is difficult due to its aggressiveness and resistance to standard chemotherapy agents. Lenvatinib is an oral targeted therapy that inhibits multiple tyrosine kinases involved in cancer cell growth and spread. Lenvatinib is FDA-approved for the treatment of RAI-refractory DTC, and it is hoped that lenvatinib may also offer an effective therapy for the treatment of ATC.

 

This trial, sponsored by Eisai Inc. is being performed in collaboration with ITOG and plans to enroll a total of 60 patients.

 

Eligible patients will have confirmed histological diagnosis of ATC and no prior treatment with lenvatinib or other tyrosine kinase inhibitors.

 

Additional information on the trial can be found at https://clinicaltrials.gov/ct2/show/NCT02657369.

 

 

Lenvatinib in ATC (Selected Sites/contact ITOG if additional information is required)

Site Primary Investigator

Site Institution

Site Location

Keith Bible, MD

Mayo Clinic - Rochester

Rochester, MN

Marcia Brose, MD, PhD

University of Pennsylvania

Philadelphia, PA

Ken Burman, MD

MedStar Washington Hospital Center

Washington, DC

Maria Cabanillas, MD

MD Anderson Cancer Center

Houston, TX

Cosimo Durante, MD

Umberto I Pol. Di Roma

Rome, Italy

Rossella Elisei, MD

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Michael Menefee, MD, PhD

Mayo Clinic - Florida

Jacksonville, FL

Laura Moss, MB BCh LLM

Velindre Cancer Centre

Cardiff, Wales, United Kingdom

Kate Newbold, MD

Royal Marsden NHS

London, England

Bruce Robinson, MD

University of Sydney

Sydney, Australia

Martin Schlumberger, MD

Institut Gustave Roussy

Villejuif, France

Eric Sherman, MD

Memorial Sloan-Kettering Cancer Center

New York City, NY

Julie Ann Sosa, MD

Duke University Health System

Durham, NC

Matthew Taylor, MD

Oregon Health and Science University

Portland, OR

Lori Wirth, MD

Jochen Lorch, MD, MSc

Massachusetts General Hospital

Dana-Farber Cancer Institute

Boston, MA