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
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Selumetinib plus RAI in RAI-avid DTC |
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Site Primary Investigator |
Site Institution |
Site Location |
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Ken Burman, MD |
MedStar Washington Hospital Center |
Washington, DC |
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Ezra Cohen, MD Greg Daniels, MD |
University of California - San Diego |
San Diego, CA |
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Ramona Dadu, MD |
MD Anderson Cancer Center |
Houston, TX |
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Bryan Haugen, MD |
University of Colorado |
Denver, CO |
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Alan Ho, MD, PhD (Study PI) |
Memorial Sloan-Kettering Cancer Center |
New York City, NY |
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Mabel Ryder, MD |
Mayo Clinic - Rochester |
Rochester, MN |
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Jennifer Sipos, MD |
Ohio State University |
Columbus, OH |
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Julie Ann Sosa, MD |
Duke University Health System |
Durham, NC |
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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.
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Lenvatinib in ATC (Selected Sites/contact ITOG if additional information is required) |
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Site Primary Investigator |
Site Institution |
Site Location |
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Keith Bible, MD |
Mayo Clinic - Rochester |
Rochester, MN |
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Marcia Brose, MD, PhD |
University of Pennsylvania |
Philadelphia, PA |
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Ken Burman, MD |
MedStar Washington Hospital Center |
Washington, DC |
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Maria Cabanillas, MD |
MD Anderson Cancer Center |
Houston, TX |
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Cosimo Durante, MD |
Umberto I Pol. Di Roma |
Rome, Italy |
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Rossella Elisei, MD |
Azienda Ospedaliero Universitaria Pisana |
Pisa, Italy |
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Michael Menefee, MD, PhD |
Mayo Clinic - Florida |
Jacksonville, FL |
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Laura Moss, MB BCh LLM |
Velindre Cancer Centre |
Cardiff, Wales, United Kingdom |
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Kate Newbold, MD |
Royal Marsden NHS |
London, England |
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Bruce Robinson, MD |
University of Sydney |
Sydney, Australia |
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Martin Schlumberger, MD |
Institut Gustave Roussy |
Villejuif, France |
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Eric Sherman, MD |
Memorial Sloan-Kettering Cancer Center |
New York City, NY |
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Julie Ann Sosa, MD |
Duke University Health System |
Durham, NC |
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Matthew Taylor, MD |
Oregon Health and Science University |
Portland, OR |
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Lori Wirth, MD Jochen Lorch, MD, MSc |
Massachusetts General Hospital Dana-Farber Cancer Institute |
Boston, MA |