Phase 2
N=58
Iodine I-131 With or Without Selumetinib in Treating Patients With Recurrent or Metastatic Thyroid Cancer
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
Bottom Line
View on ClinicalTrials.gov: NCT02393690 ↗Enrolled (actual)
58
Serious AEs
5.2%
Results posted
Aug 2021
Primary outcome: Primary: Response at 6 Months — 7; 2 Participants — p=0.0787
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Iodine I-131 (Radiation); Placebo Administration (Other); Selumetinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Academic and Community Cancer Research United
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response at 6 Months |
7; 2 | 0.0787 |
| SECONDARY Overall Response Rate |
7; 2 | 0.0787 |
| SECONDARY Progression Free Survival (PFS) |
19; 10.2 | 0.1764 |
| SECONDARY Changes in Serum Thyroglobulin Levels |
-29.1; 4.3 | 0.0756 |
| SECONDARY Incidence of Adverse Events |
6; 1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of recurrent and/or metastatic thyroid cancer
- Histological or cytological confirmation of thyroid carcinoma of follicular origin (including papillary, follicular, or poorly differentiated subtypes and their respective variants); NOTE: medullary and anaplastic thyroid cancers are excluded; Hurthle cell carcinomas are excluded (defined as having an invasive tumor composed of > 75% oncocytic [Hurthle] cells lacking the nuclear features of papillary carcinoma, tumor necrosis, and marked mitotic activity); patients with oncocytic (Hurthle cell) variants of papillary thyroid carcinoma (defined as a tumor composed of a majority of oncocytic [Hurthle] cells having the nuclear features of papillary carcinoma) are eligible to participate
- RAI-avid lesion on a radioiodine scan (a diagnostic, post-therapy, or post-ablation scans) performed = = 1 cm in the long axis,
- It is pathologically proven to be involved with thyroid cancer (by cytology or pathology) and it measures >= 1 cm in the long axis, or
- Its short axis is >= 1.5 cm when assessed by computed tomography (CT) scan NOTE 2: Patients only with biochemical evidence of disease without structural evidence of cancer are not eligible for this study
- For patients with non-measurable, structural disease the following must apply:
- Undetectable thyroglobulin antibody AND
- A serum thyroglobulin of 10 ng/ml or greater in the context of suppressed thyroid-stimulating hormone (TSH) (TSH = = 1500/mm^3 (obtained = = 100,000/mm^3 (obtained = 9.0 g/dL (obtained = = 50 ml/min by either the Cockcroft-Gault formula or 24-hours urine collection analysis (obtained = 800 mCi (excluding 131I activity administered for diagnostic scans)
- Treatment with chemotherapy or targeted therapy (e.g. tyrosine kinase inhibitor) = Common Terminology Criteria for Adverse Events (CTCAE) grade 2 from previous anti-cancer therapy, except for alopecia
- Cardiac conditions as follows:
- Uncontrolled hypertension (blood pressure [BP] >=150/95 mmHg despite medical therapy)
- Left ventricular ejection fraction 100 beats per minute (bpm) on electrocardiogram (ECG) at rest
- Symptomatic heart failure (New York Heart Association [NYHA] grade II-IV)
- Prior or current cardiomyopathy
- Severe valvular heart disease
- Uncontrolled angina (Canadian Cardiovascular Society grade II-IV despite medical therapy)
- Acute coronary syndrome = 21 mmHg, or uncontrolled glaucoma (irrespective of intra-ocular pressure)
- Current or past history of central serous retinopathy or retinal vein occlusion
- Symptomatic or untreated leptomeningeal disease, brain metastasis, or spinal cord compression
- Unable to follow a low iodine diet or requiring medication with high content in iodide (e.g., amiodarone)
- Received iodinated intravenous contrast within =< 2 months of registration; avoidance of iodinated oral contrast is also preferred but not strictly required for study enrollment; NOTE: those who have had iodinated intravenous contrast within this time frame may still be eligible if a urinary iodine analysis reveals that excess iodine has been cleared (defined as urinary iodine documented to be < 300 mcg/day by either a spot urinary iodine or 24-hour urinary iodine measurement)
- Any of the following:
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy; NOTE: patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
- Uncontrolled intercurrent illness incl
Data sourced from ClinicalTrials.gov (NCT02393690). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.