RecruitingPhase 2NCT03206060

Lu-177-DOTATATE (Lutathera) in Therapy of Inoperable Pheochromocytoma/ Paraganglioma


Sponsor

National Cancer Institute (NCI)

Enrollment

130 participants

Start Date

Oct 10, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

Background: Pheochromocytoma and paraganglioma are rare tumors. They usually form inside and near the adrenal gland or in the neck region. Not all these tumors can be removed with surgery, and there are no good treatments if the disease has spread. Researchers think a new drug may be able to help. Objective: To learn the safety and tolerability of Lu-177-DOTATATE. Also, to see if it improves the length of time it takes for the cancer to return. Eligibility: Adults who have an inoperable tumor of the study cancer that can be detected with Ga-68-DOTATATE PET/CT imaging Design: Participants will be screened with a medical history, physical exam, and blood tests. Eligible participants will be admitted to the NIH Clinical Center. Participants will get the study drug in an intravenous infusion. They will get 4 doses, given about 8 weeks apart. Between 4 and 24 hours after each study drug dose, participants will have scans taken. They will lie on their back on a scanner table. Participants will have vital signs taken. They will give blood and urine samples. During the study, participants will have other scans taken. Some scans will use a radioactive tracer. Participants will complete quality of life questionnaires. Participants will be contacted by phone 1-3 days after they leave the Clinical Center. They will then be followed every 3 to 6 months for 3 years or until their disease gets worse.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a radioactive drug called lutetium-177 DOTATATE (also known as Lutathera) — which seeks out and delivers targeted radiation directly to tumour cells — for people with pheochromocytoma or paraganglioma (rare tumours of nerve tissue near the adrenal glands) that cannot be surgically removed and are continuing to grow. **You may be eligible if...** - You have been diagnosed with pheochromocytoma or paraganglioma confirmed by tissue biopsy - Your tumour cannot be surgically removed - Your cancer has been growing over the past 12 months (shown on imaging) - The tumour is not associated with a known hereditary genetic syndrome (or you have a specific mutation that makes you eligible) - You have not had this type of targeted radiation treatment before **You may NOT be eligible if...** - Your tumour is surgically removable - Your disease is not progressing - You have had prior lutetium-177 DOTATATE treatment - You have poor kidney function or other major organ problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLu-177-DOTATATE

Lu-177-DOTATATE IV at weeks 1, 8, 16 and 24.

DRUGGa-68-DOTATATE

Ga-68-DOTATATE PET/CT at weeks 15 and 31, every 24 weeks during 3 years follow up period.


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT03206060


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