Trametinib in Increasing Tumoral Iodine Incorporation in Patients With Recurrent or Metastatic Thyroid Cancer

Part of paid clinical trials in New York, New York.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02152995
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Metastatic Thyroid Gland Carcinoma
  • Poorly Differentiated Thyroid Gland Carcinoma
  • Recurrent Thyroid Gland Carcinoma
  • Refractory 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

  • Computed Tomography — PROCEDURE
    Undergo iodine I-124 PET/CT
  • Iodine I 124 — OTHER
    Undergo iodine I-124 PET/CT
  • Iodine I-131 — RADIATION
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pharmacodynamic Study — OTHER
    Correlative studies
  • Positron Emission Tomography — PROCEDURE
    Undergo iodine I-124 PET/CT
  • Trametinib — DRUG
    Given PO

Study Details

This phase II trial studies how well trametinib works in increasing tumoral iodine incorporation in patients with thyroid cancer that has come back or spread to another place in the body. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and may help make treatment with iodine I-131 more effective.

Key Dates

Start date
Aug 14, 2014
Status verified
Feb 2026
Primary completion
Aug 25, 2021
Completion
Feb 5, 2027

Study Design

Enrollment
34 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A (iodine I-124 PET/CT, trametinib, iodine I-131)
    Patients with RAS gene mutations undergo iodine I-124 PET/CT on day 5 of week 1. Beginning day 6, patients receive trametinib PO daily for 4 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo second iodine I-124 PET/CT on week 5. If I-124 PET/CT shows enough iodine absorption, patients may receive iodine I-131 PO and continue receiving trametinib for another 2 days. If I-124 shows that the thyroid is not absorbing iodine, patients have the option to be assigned to Cohort C.
  • Experimental: Cohort B (iodine I-124 PET/CT, trametinib, iodine I-131)
    Patients without BRAF/RAS gene mutations undergo iodine I-124 PET/CT on day 5 of week 1. Beginning day 6, patients receive trametinib PO daily for 4 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo second iodine I-124 PET/CT on week 5. If I-124 PET/CT shows enough iodine absorption, patients may receive iodine I-131 PO and continue receiving trametinib for another 2 days. If I-124 shows that the thyroid is not absorbing iodine, patients have the option to be assigned to Cohort C.
  • Experimental: Cohort C (trametinib)
    Patients may continue trametinib at the doctor's discretion and do not receive iodine I-131.

Primary Outcome Measure

Percentage of Patients Progression Free at 6 Months Following Treatment With Trametinib and I-124 (Cohort A) [ Time Frame: At 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-

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By research site
Memorial Sloan Kettering Cancer Center· New York, NY

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