Study on 177Lu-DOTA-EB-TATE for Adults with Advanced Hurthle-Cell Thyroid Cancer

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06991738

Provider View

This clinical trial is testing a new radioactive drug, 177Lu-DOTA-EB-TATE, to see if it can help treat Hurthle-cell thyroid cancer that has spread and does not respond to standard radioactive treatments.

Patient Parameters

Program Overview

This study is exploring a new treatment for Hurthle-cell thyroid cancer (HTC), a rare type of thyroid cancer that doesn't respond to usual radioactive treatments and has spread to other parts of the body. The treatment involves a radioactive drug called 177Lu-DOTA-EB-TATE, which targets a specific protein found in high amounts on HTC cancer cells. The main goals are to determine if the drug is safe, to find the best dose, and to see if it can help control the cancer. Participants will receive the drug through a vein in four sessions, each spaced 8 to 12 weeks apart, and will stay in the hospital for a few days after each session. Follow-up visits will continue for up to five years to monitor health and treatment effects.

Description

This study is testing a new treatment for adults with Hurthle-cell thyroid cancer that has spread and does not respond to standard radioactive iodine treatments. The treatment uses a radioactive drug called 177Lu-DOTA-EB-TATE, which targets cancer cells with a specific protein. The study aims to find the safest and most effective dose of the drug and to see if it can help control the cancer.

Participants will receive the drug through an IV in four sessions, each 8 to 12 weeks apart. After each session, they will stay in the hospital for 4 to 10 days, spending about 24 hours in a special room until radiation levels decrease. Follow-up visits will include scans, blood and urine tests, and heart function tests. Participants will also complete questionnaires about their quality of life.

The study will monitor the safety of the drug, how well it works, and any side effects. Researchers will also look at how the drug affects tumor markers and quality of life over time. Follow-up visits will continue for up to five years after the last treatment session.

Eligibility Criteria

Inclusion Criteria

  • Aged 18 years or older.
  • Have Hurthle-cell thyroid cancer that has spread and does not respond to standard radioactive iodine treatments.
  • Cancer must be progressing, with or without symptoms, within the last 12 months.
  • High levels of a specific protein in at least one cancerous area, as shown by a special scan within 12 weeks before joining the study.

Exclusion Criteria

  • Pregnant or breastfeeding.
  • Certain imaging results showing more than two cancer areas that do not have the target protein.
  • Allergic reactions to similar drugs.
  • Weigh more than 500 lbs due to equipment limits.
  • Cannot tolerate certain imaging tests.
  • Recent cancer treatments or surgeries that do not meet study timelines.
  • Life expectancy less than 6 months.
  • Poor overall health or organ function.
  • Active infections or other serious health conditions.
  • Previous treatments that affect bone marrow or kidney function.
  • Other active cancers, except for certain skin or cervical cancers.
  • Unable to follow study requirements or provide informed consent.

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