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Trametinib for Thyroid Cancer
Study Summary
This trial studies the effectiveness of trametinib in increasing iodine uptake in patients with thyroid cancer that has returned or spread. 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.
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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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- I have brain or spinal cord cancer symptoms that are not treated.I have a history of heart problems.I have specific eye conditions.I cannot follow a low iodine diet or need medication high in iodide.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.My thyroid cancer has been confirmed and is of follicular origin.I am not pregnant or nursing, as the study drug may be unsafe.I am not currently using any medications that are not allowed in the study.You have had a bad reaction to drugs similar to trametinib or to certain other substances.I can take care of myself but might not be able to do heavy physical work.I haven't taken any experimental drugs in the last 28 days or more.I have had interstitial lung disease or pneumonitis.I've been cancer-free for 3 years, or had non-melanoma skin cancer removed, or have a slow-growing secondary cancer.I do not have active HIV, HBV, or HCV, or I have chronic/cleared HBV or HCV.I've had a dye injection for a scan within the last 3 months but may still qualify if tests show the dye is cleared from my body.Your disease does not respond to radioactive iodine treatment, as shown in imaging tests.I haven't had recent thyroid cancer treatment.You are expected to live for more than 3 months.All my side effects from previous treatments are mild, except for hair loss.Your body has enough infection-fighting white blood cells.Your hemoglobin level is at least 9 grams per deciliter.I agree to use birth control during and 4 months after the study, and I am not pregnant.My cancer has a specific mutation in NRAS, KRAS, or HRAS.Your AST and ALT levels are not more than 2.5 times the normal limit at the hospital where you are being treated.My kidney function is normal, based on creatinine levels or clearance.Your heart's pumping function is within the normal range based on specific heart tests.My cancer is BRAF/RAS wild type.I can provide tissue samples from my thyroid cancer for the study.My cancer has worsened or spread in the last 14 months.My thyroid tumor lacks certain genetic mutations.My thyroid tumor has a specific mutation (NRAS, KRAS, or HRAS).You must have a platelet count of at least 100 billion per liter.I have a tumor that can be measured and has grown after radiation.Your albumin level in the blood is at least 2.5 grams per deciliter.I am not HIV-positive or not on antiretroviral therapy.Your total bilirubin level is within a certain range considered normal at the hospital.Your blood clotting time is within the normal range.I agree to have two biopsies unless certain conditions apply.I can take pills and don't have major stomach or bowel issues affecting drug absorption.My cancer has a BRAF V600 mutation.
- Group 1: Cohort A (iodine I-124 PET/CT, trametinib, iodine I-131)
- Group 2: Cohort B (iodine I-124 PET/CT, trametinib, iodine I-131)
- Group 3: Cohort C (trametinib)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What health risks are associated with Computed Tomography?
"Since there is only some data supporting safety, and no data yet to support efficacy, Computed Tomography receives a score of 2."
What is one popular reason why Computed Tomography scans are used?
"Many patients that suffer from hyperthyroidism receive Computed Tomography as part of their treatment plan. This technology is also used to help those with thyroid gland, metastatic melanoma, and unresectable melanoma."
What are the goals of this particular clinical trial?
"The primary objective of this medical trial is to observe the effects of radioiodine therapy on thyroid cancer metastases. This will be monitored over a period of six months. Secondary objectives include observing changes in thyroglobulin levels and assessing the incidence of toxicity associated with the treatment."
Is this a fully subscribed clinical trial or are there still opportunities for new participants?
"This clinical trial is not searching for patients at the moment. The last time it did was on April 5th, 2022. However, there are 3574 other trials actively enrolling participants with refractory thyroid gland carcinoma and 101 trials for Computed Tomography that you could explore."
What other medical research has utilized Computed Tomography?
"There are presently one hundred and one clinical trials underway that are studying Computed Tomography. Of those, six have progressed to Phase 3 testing. Most of the research surrounding this topic is based in Saint Louis, Missouri; however, there are five thousand eight hundred and nineteen other locations worldwide where these studies are taking place."
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