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Iodine I-131 With or Without Selumetinib in Treating Patients With Recurrent or Metastatic Thyroid Cancer

NCT02393690 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-07-26

Study results available
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Summary

This phase II trial studies how well iodine I-131 works with or without selumetinib in treating patients with thyroid cancer that has returned (recurrent) or has spread from where it started to other places in the body (metastatic). Many thyroid cancers absorb iodine. Due to this, doctors often give radioactive iodine (iodine I-131) alone to treat thyroid cancer as part of standard practice. It is thought that the more thyroid tumors are able to absorb radioactive iodine, the more likely it is that the radioactive iodine will cause those tumors to shrink. Selumetinib may help radioactive iodine work better in patients whose tumors still absorb radioactive iodine. It is not yet known whether iodine I-131 is more effective with or without selumetinib in treating thyroid cancer.

Conditions

  • Metastatic Thyroid Gland Carcinoma
  • Poorly Differentiated Thyroid Gland Carcinoma
  • Recurrent Thyroid Gland Carcinoma
  • Stage IV Thyroid Gland Follicular Carcinoma AJCC v7
  • Stage IV Thyroid Gland Papillary Carcinoma AJCC v7
  • Stage IVA Thyroid Gland Follicular Carcinoma AJCC v7
  • Stage IVA Thyroid Gland Papillary Carcinoma AJCC v7
  • Stage IVB Thyroid Gland Follicular Carcinoma AJCC v7
  • Stage IVB Thyroid Gland Papillary Carcinoma AJCC v7
  • Stage IVC Thyroid Gland Follicular Carcinoma AJCC v7
  • Stage IVC Thyroid Gland Papillary Carcinoma AJCC v7

Interventions

RADIATION

Iodine I-131

Given PO

OTHER

Placebo Administration

Given PO

DRUG

Selumetinib

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Academic and Community Cancer Research United

    lead OTHER

Principal Investigators

  • Alan L Ho · Academic and Community Cancer Research United

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-04
Primary Completion
2020-07-17
Completion
2023-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02393690 on ClinicalTrials.gov