177Lu-DOTA-EB-TATE for Thyroid Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new radioactive treatment called 177Lu-DOTA-EB-TATE, aimed at combating Hurthle cell thyroid cancer (HTC), a rare type of thyroid cancer. The goal is to determine if the treatment can effectively target and shrink cancer that has spread and does not respond to standard radioactive therapies. Suitable participants have HTC that has not responded to conventional treatments and has metastasized. Participants will receive four infusions of the treatment and will need to stay in the hospital for a few days each time to monitor radiation levels and health. The study includes follow-up visits for up to five years to track the treatment's long-term effects. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you have had chemotherapy, targeted cancer therapy, or immunotherapy, you must wait at least 4 weeks before starting the study drug.
Is there any evidence suggesting that 177Lu-DOTA-EB-TATE is likely to be safe for humans?
Previous studies have explored 177Lu-DOTA-EB-TATE for its ability to target certain cancer cells in thyroid cancer. The treatment shows promise, but understanding its safety is crucial. Research indicates that this treatment has been used in other cancers with similar cell targets and was generally well-tolerated. Most side effects were mild to moderate, with some individuals experiencing nausea or fatigue, but these were not severe.
As the trial is in the early to mid-phase, researchers are still collecting safety data. This phase provides some initial evidence of safety, but further review is needed to confirm its safety for thyroid cancer patients. Overall, while potential side effects exist, early findings suggest that 177Lu-DOTA-EB-TATE could be a safe option for those who have not responded to other treatments.12345Why are researchers excited about this study treatment for thyroid cancer?
Researchers are excited about 177Lu-DOTA-EB-TATE for thyroid cancer because it targets the cancer cells with high precision using a radioactive isotope, which is different from the traditional chemotherapy and radioactive iodine treatments. Unlike current options that may not work well for radioactive iodine non-responsive cases, this treatment combines a radionuclide with a targeting peptide, allowing it to deliver radiation directly to the cancer cells while sparing healthy tissue. Additionally, the study is exploring a 3-dose regimen with escalating doses, aiming to maximize efficacy and safety for patients with this challenging form of thyroid cancer.
What evidence suggests that 177Lu-DOTA-EB-TATE might be an effective treatment for thyroid cancer?
Research has shown that 177Lu-DOTA-EB-TATE, the investigational treatment in this trial, targets a specific protein called somatostatin receptor type 2 (SSTR2), often found in large amounts on Hurthle cell thyroid cancer (HTC) cells. This radioactive drug attaches to these proteins and delivers radiation directly to the cancer cells, potentially shrinking tumors. Similar treatments have proven effective for other types of thyroid cancer, especially when patients no longer respond to standard radioactive iodine treatments. Early results suggest that this method may improve outcomes for people with metastatic HTC, offering a new option for those with limited choices.12367
Who Is on the Research Team?
Joanna Klubo-Gwiezdzinska, M.D.
Principal Investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Are You a Good Fit for This Trial?
Adults over 18 with metastatic Hurthle cell thyroid cancer that hasn't responded to radioactive iodine treatment can join. They must have spread of cancer beyond the thyroid and be able to stay in the hospital for several days post-infusion.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 4 infusions of 177Lu-DOTA-EB-TATE, spaced 8 to 12 weeks apart, with hospital stays of 4 to 10 days after each infusion
Follow-up
Participants have 4 to 6 follow-up visits after each infusion, including imaging scans, blood and urine tests, and heart function tests
Long-term Follow-up
Participants will have follow-up visits for 5 years after their last study treatment to monitor safety and efficacy
What Are the Treatments Tested in This Trial?
Interventions
- 177Lu-DOTA-EB-TATE
Trial Overview
The trial is testing a new radioactive drug, 177Lu-DOTA-EB-TATE, targeting proteins on HTC cells. Participants will receive four infusions spaced out every 8-12 weeks and undergo various scans, blood tests, and heart function assessments.
How Is the Trial Designed?
Concomitant administration of an amino acid infusion with the study drug 177Lu-DOTA-EB-TATE is for renal protection.
The radiopharmaceutical 68Ga-DOTATATE is acquired by the NIH PET department in the Clinical Center. The radiopharmaceutical is synthetized on the day of the study and a premade dose of 5 mCi is administered.
Open-Label Study of the Safety, Dosimetry and Efficacy of a 3-Dose Regimen of Escalating Doses of 177Lu-DOTA-EB-TATE in Adult Patients with Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Lead Sponsor
Citations
NCT06991738 | 177Lu-DOTA-EB-TATE in Adult Patients ...
The proposed indication is for the treatment of somatostatin receptor-positive radioactive iodine (RAI) non-responsive metastatic oncocytic (Hurthle cell) ...
177Lu-DOTA-EB-TATE, A Radiolabeled Analog of ...
The goal of this study was to analyze the role of somatostatin receptor type 2 (SSTR2) as a molecular target for the imaging and treatment of thyroid cancer ...
3.
aacrjournals.org
aacrjournals.org/clincancerres/article/27/5/1399/84000/177Lu-DOTA-EB-TATE-a-Radiolabeled-Analogue-of177Lu-DOTA-EB-TATE, a Radiolabeled Analogue of ...
The goal of this study was to analyze the role of somatostatin receptor type 2 (SSTR2) as a molecular target for the imaging and treatment of thyroid cancer ...
Data from 177 Lu-DOTA-EB-TATE, a Radiolabeled Analogue ...
The goal of this study was to analyze the role of somatostatin receptor type 2 (SSTR2) as a molecular target for the imaging and treatment of thyroid ...
Efficacy and safety of peptide receptor radionuclide therapy in ...
... thyroid Cancer long-term results of a phase 2 clinical trial. Cancer ... The effectiveness of 177Lu-DOTATATE in patients with metastatic medullary ...
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, ...
To determine the optimal dose of 177Lu-DOTA-EB-TATE that is both safe and shows sufficient efficacy for treatment of metastatic HTC based on TITE-BOIN12 design ...
Peptide Receptor Radionuclide Therapy in Thyroid Cancer
Peptide receptor radionuclide therapy (PRRT) has the potential to be an effective and safe modality for treating patients with somatostatin receptor (SSTR)+ ...
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