At a glance
ClinicalIndex Comparison Record- ✓Surgically inoperable with histologically confirmed PHEO/PGL
- ✓Progressive disease by RECIST 1.1 within last 12 months
- ✓PHEO/PGL with SDHx mutation or apparent sporadic (no non-SDHx mutations)
- ✓Non-SDHx mutations (VHL, NF1, RET) excluded
- ✕Creatinine clearance <50 mL/min by MDRD
- ✕Serum albumin ≤3.0 g/dL unless normal prothrombin time
- ✕AST or ALT >2.5x ULN (>5x if liver metastases)
- ✕Child Class C liver disease or worse
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Lu-177-DOTATATE (Lutathera) in Therapy of Inoperable Pheochromocytoma/ Paraganglioma
In Brief
A Phase 2 clinical trial evaluating Lu-177-DOTATATE and Ga-68-DOTATATE for Pheochromocytoma and 3 related conditions. Currently recruiting, targeting 130 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Lu-177-DOTATATE IV at weeks 1, 8, 16 and 24.
Ga-68-DOTATATE PET/CT at weeks 15 and 31, every 24 weeks during 3 years follow up period.