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Radioisotope Therapy

Lutathera for Pheochromocytoma/Paraganglioma

Phase 2

Recruiting

Led By Frank I Lin, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Surgically inoperable participants with clinical diagnosis of PHEO/PGL with demonstrated disease histologically consistent with pheochromocytoma or paraganglioma

Ineligible, unable to, or unwilling to receive standard first-line therapy for PHEO/PGL

Must not have

Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix

Creatinine clearance <50 mL/min

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, Lu-177-DOTATATE, to see if it is safe and effective in treating rare tumors.

Who is the study for?

Adults with inoperable pheochromocytoma or paraganglioma that shows up on a Ga-68-DOTATATE PET/CT scan. They should have progressive disease, no severe liver or kidney issues, and not be pregnant. Participants must agree to use non-hormonal contraception for 6 months post-treatment if of childbearing potential.

What is being tested?

The trial is testing Lu-177-DOTATATE's safety and effectiveness against rare tumors near the adrenal gland or neck region. Patients receive four intravenous doses about eight weeks apart, followed by scans and regular check-ups including quality of life assessments over three years.

What are the potential side effects?

Possible side effects include nausea, vomiting, fatigue, blood cell count changes leading to increased infection risk, kidney damage, and potentially allergic reactions to the infusion. Long-term risks may involve bone marrow suppression and secondary cancers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tumor is a pheochromocytoma or paraganglioma and cannot be removed with surgery.

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I cannot or do not want to receive standard treatment for my PHEO/PGL.

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My tumor is not linked to genetic mutations, except for SDHx.

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I am 18 years old or older.

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I can care for myself but may not be able to do active work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have no other cancers except for non-melanoma skin cancer or cervical carcinoma in situ.

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My kidney function is reduced with a creatinine clearance below 50 mL/min.

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My liver function is severely impaired.

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My heart failure is severe, making daily tasks very difficult.

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I have had cancer treatment with radioactive materials.

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I do not have any uncontrolled illnesses.

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I cannot tolerate certain types of body scans.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

progression-free survival

Secondary study objectives

Determine ability to decrease anti-hypertensive medication

Determine changes in plasma biochemical markers

Evaluate Quality of Life

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 1/Lu-177-DOTATATEExperimental Treatment4 Interventions

Lu-177-DOTATATE is administered IV every 8 (+/- 2) weeks, for a total of 4 administrations. A Ga-68-DOTATATE PET and F-18-FDG-PET, as well as CT/ MRI for RECIST monitoring, will be obtained post 2 administrations and post 4 administrations. Concomitant administration of an IV infusion of an amino acid (AA) solution will also be done for renal protection. Concomitant administration of an IV infusion of an amino acid (AA) solution will also be done for renal protection.

0 / 12Eligibility criteria met