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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Iodine I-131 — RADIATION
  Given PO
• Placebo Administration — OTHER
  Given PO
• Selumetinib — DRUG
  Given PO

Study Details

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.

Key Dates

Start date

May 4, 2015

Status verified

Jun 2024

Primary completion

Jul 17, 2020

Completion

Dec 31, 2023

Study Design

Enrollment

60 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (selumetinib, iodine I-131)
  Patients receive selumetinib PO BID starting on week 1, day 1 and continuing through 2 days after iodine I 131 therapy has been administered. Approximately 3 weeks after beginning treatment with selumetinib, patients receive iodine I-131 PO.
• Active Comparator: Arm II (placebo, iodine I-131)
  Patients receive placebo PO BID starting on week 1, day 1 and continuing through 2 days after iodine I-131 therapy has been administered. Approximately 3 weeks after beginning treatment with placebo, patients receive iodine I-131 PO.

Primary Outcome Measure

Response at 6 Months [ Time Frame: At 6 months ]

Locations (11)

Find similar trials in La Jolla, CA

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