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Iodine I-131 + Selumetinib for Thyroid Cancer
Study Summary
This trial will study whether iodine I-131, with or without selumetinib, is more effective in treating patients with thyroid cancer that has returned or has spread from where it started to other places in the body.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- Your hemoglobin level is higher than 9.0 grams per deciliter.You must have a certain amount of a type of white blood cell called neutrophils in your blood.You have at least 100,000 platelets per cubic millimeter of blood.Your total bilirubin level should be normal or slightly higher than normal.You are able to carry out normal activities without any restrictions (ECOG performance status 0, 1 or 2).You have been diagnosed with thyroid cancer that comes from follicular cells.You have a specific type of lesion that can be treated with radioactive iodine therapy, as determined by the doctor.You have a visible disease in medical tests or scans.You have received 131I therapy within the last 6 months.You have had external beam radiation therapy within 28 days before signing up for the trial.Your kidney function, measured by creatinine levels, needs to be within a certain range.You have taken certain types of medications for a specific kind of cancer in the past.You still have side effects from previous cancer treatment that are more severe than mild, unless it's just hair loss.Heart conditions as specifiedYou have serious ongoing health issues.You have received a total of more than 800 millicuries of 131I treatment in your lifetime.You have been diagnosed with thyroid cancer that has come back or spread to other parts of the body.Your liver enzyme levels are not too high, unless you have cancer that has spread to the liver.Women who could become pregnant must have a negative pregnancy test within 7 days before joining the study.You have specific eye conditions as listed in the criteria.You have symptoms or are not receiving treatment for cancer that has spread to the brain or spinal cord.You have had a special type of contrast dye through a vein in the last two months.You have a weakened immune system, or you have HIV and are currently on antiretroviral therapy.You have had another type of cancer in the past 2 years that could affect this trial.
- Group 1: Arm II (placebo, iodine I-131)
- Group 2: Arm I (selumetinib, iodine I-131)
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many sites are hosting this experiment?
"This clinical study is recruiting patients in 11 cities, including Columbus, Durham and La Jolla. To reduce travel expenses, it's best to select the closest trial centre."
Has the federal agency granted approval of Iodine I-131?
"It is believed that Iodine I-131's safety can be rated a 2 according to the clinical trials data since this is only in Phase 2 and there is no evidence for efficacy but some for safety."
Has a research project such as this one been conducted previously?
"Presently, there are 39 ongoing trials for Iodine I-131 distributed across 162 cities and 33 nations. The very first assessment of the drug was conducted in 2007 by AstraZeneca with a cohort of 58 volunteers to seek Phase 1 approval. Since then, 77 experiments have been concluded thus far."
What is the estimated participation rate of this clinical study?
"This clinical trial has ceased its search for patients, as the last update was made on August 25th 2022. However, if you are still hunting for a medical study to join, there are presently 3447 trials recruiting those with relapse and 39 studies searching for participants taking Iodine-131."
Are there vacancies available for participants within this clinical trial?
"This medical experiment is no longer enrolling patients. Its initial posting date was May 4th 2015 and the most recent amendment was August 25th 2022. Alternatively, there are 3447 trials related to relapse and 39 studies focusing on Iodine I-131 that have open recruitment spots."
To what specific ailments is Iodine I-131 commonly administered?
"Iodine I-131 is typically prescribed to treat hyperthyroidism, as well as illnesses such as thyroid gland disorders, neurofibroma, and radioactive iodide uptake tests."
Have any previous research studies explored the use of Iodine I-131?
"Presently, 39 live clinical studies are investigating the potential of Iodine I-131. 5 of those trials have entered Phase 3 and 1015 medical centres across the United States are hosting them; primarily in Boston, Massachusetts."
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