177Lu-DOTA-EB-TATE for Thyroid Cancer

Overseen By Joanna Klubo-Gwiezdzinska, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

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

Must not be taking: Chemotherapy, Immunotherapy, others

Disqualifiers: Pregnancy, Renal dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 21

Duration: 32-48 weeks

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Background: Oncocytic (Hurthle cell) thyroid cancer (HTC) is a rare disease with few treatment options. Researchers are developing a radioactive drug that targets a protein that appears in high numbers on HTC cancer cells. Objective: To test a radioactive drug (177LuDOTA-EB-TATE) in people with HTC. Eligibility: People aged 18 years and older with HTC. The HTC must have failed to respond to conventional radioactive treatment; it must also have spread to other parts of the body. Design: Participants will be screened. They will have a physical exam with blood tests. They will have imaging scans and a test of their heart function. 177LuDOTA-EB-TATE is infused into a vein. Participants will receive 4 infusions spaced 8 to 12 weeks apart. They will stay in the hospital for 4 to 10 days after each infusion. During and after each infusion, participants will remain in a lead-lined room until their radiation levels go down; this usually takes about 24 hours. Participants will have 4 to 6 follow-up visits in the weeks after each infusion. Procedures will vary at each visit, but may include more imaging scans; blood and urine tests; and tests of heart function. Participants will have 2 single-photon emission computerized tomography (SPECT) scans. SPECT scans show where the study drug is sticking to tumors or maybe other parts of their body. They will lie on a table while a machine rotates around them. Participants will fill in questionnaires about how their thyroid condition affects their life. Participants will have follow-ups visits for 5 years after their last study treatment.

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

I am 18 years old or older.

My thyroid cancer does not respond to radioactive iodine treatment.

My cancer has worsened in the last year according to scans.

Exclusion Criteria

My kidney function is reduced with a creatinine clearance below 60 mL/min.

My liver is not working well.

NET/PET score of 5 by imaging with 68Ga-DOTATATE PET/CT and 18FDG-PET/CT

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

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

32-48 weeks

4 hospital stays (in-person)

Follow-up

Participants have 4 to 6 follow-up visits after each infusion, including imaging scans, blood and urine tests, and heart function tests

8-12 weeks after each infusion

16-24 visits (in-person)

Long-term Follow-up

Participants will have follow-up visits for 5 years after their last study treatment to monitor safety and efficacy

5 years

Annual visits (in-person)

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?

Group I: Amino acid infusions Experimental Treatment 2 Interventions

Concomitant administration of an amino acid infusion with the study drug 177Lu-DOTA-EB-TATE is for renal protection.

Group II: 68Ga-DOTA-TATE PET Scan Experimental Treatment 1 Intervention

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.

Group III: 177Lu-DOTA-EB-TATE Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

2,513

Recruited

4,366,000+