Study on Lu-177-DOTATATE (Lutathera) for Treating Inoperable Pheochromocytoma/Paraganglioma

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03206060

Provider View

This clinical trial is testing a new drug, Lu-177-DOTATATE, to see if it is safe and can help delay the return of cancer in adults with inoperable pheochromocytoma or paraganglioma, which are rare tumors that cannot be removed by surgery.

Patient Parameters

Program Overview

Pheochromocytoma and paraganglioma are rare tumors that usually form near the adrenal gland or in the neck. They can be difficult to treat if they cannot be removed with surgery or if they have spread. This study is testing a new drug, Lu-177-DOTATATE, to see if it is safe and can help delay the return of cancer. Participants will receive the drug through an IV infusion, with four doses given about eight weeks apart. They will have scans and tests to monitor their health and the drug's effects. The study will follow participants for up to three years to see how they respond to the treatment.

Description

Pheochromocytomas and paragangliomas (PHEOs/PGLs) are rare tumors that develop from nerve tissue. They can occur in the adrenal gland (PHEOs) or outside it (PGLs). While surgery can treat some of these tumors, others cannot be removed, especially if they have spread or are located in difficult areas like the head and neck. This study is testing Lu-177-DOTATATE, a drug that targets specific receptors on these tumors, to see if it can help control the disease.

The study involves giving the drug through an IV every eight weeks for a total of four doses. Participants will have scans to check how the drug is working and to ensure it targets the tumors. They will also complete quality of life questionnaires and have regular follow-ups to monitor their health.

Participants who respond well to the treatment may be eligible for additional doses if their cancer progresses. The study aims to improve the time it takes for the cancer to return and to assess the safety of the drug in this patient group.

Eligibility Criteria

Inclusion Criteria

  • Adults with inoperable pheochromocytoma or paraganglioma that cannot be removed by surgery.
  • Tumors must be detectable with a specific type of scan (Ga-68-DOTATATE PET/CT).
  • Must have progressive disease within the last 12 months.
  • Tumors should not be linked to certain genetic mutations, except for SDHx mutation.
  • Must be 18 years or older.
  • Must have a performance status that allows for daily activities.
  • Must agree to use effective contraception during and after the study.
  • Must have a healthcare provider to follow up after treatment.
  • Must be receiving appropriate medication if tumors are producing hormones.

Exclusion Criteria

  • Poor kidney function or liver dysfunction.
  • Low blood cell counts or severe anemia.
  • Severe heart failure symptoms.
  • Pregnant or breastfeeding women.
  • Previous treatment with certain types of radiation therapy.
  • Untreated or unstable brain metastases.
  • Other active cancers, except for certain skin or cervical cancers.
  • Recent participation in another clinical trial.
  • Weight over 400 lbs (due to scanner limits).
  • Uncontrolled medical conditions, such as infections or severe heart problems.
  • Inability to undergo necessary imaging tests.

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