OncoMatch/Clinical Trials/NCT03206060
Lu-177-DOTATATE (Lutathera) in Therapy of Inoperable Pheochromocytoma/ Paraganglioma
Is NCT03206060 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Lu-177-DOTATATE and Ga-68-DOTATATE for pheochromocytoma.
Treatment: Lu-177-DOTATATE · Ga-68-DOTATATE — 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. ...
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroendocrine Tumor
Biomarker criteria
Excluded: VHL mutation
PHEO/PGL that is associated with non-SDHx mutations such as VHL, NF1, and RET will not be eligible for this study.
Excluded: NF1 mutation
PHEO/PGL that is associated with non-SDHx mutations such as VHL, NF1, and RET will not be eligible for this study.
Excluded: RET mutation
PHEO/PGL that is associated with non-SDHx mutations such as VHL, NF1, and RET will not be eligible for this study.
Allowed: SDHX mutation
PHEO/PGL that is not associated with any known susceptibility genetic mutations for PHEO/PGL except SDHx mutation (a.k.a. "apparent sporadic"), based on documented genetic testing results obtained prior to study enrollment.
Prior therapy
Cannot have received: anti-tumoral radionuclide therapy with unsealed sources
Exception: Prior therapy with sealed radioactive sources such as brachytherapy will be allowed.
Prior anti-tumoral radionuclide therapy with unsealed sources. Prior therapy with sealed radioactive sources such as brachytherapy will be allowed.
Lab requirements
Blood counts
Hb < 8.0 g/dL; WBC < 2.0 x 10^9/L (or ANC < 1000); Platelets < 100 x 10^9/L excluded; Serum albumin ≤ 3.0 g/dL unless prothrombin time is within normal range
Kidney function
Creatinine clearance <50 mL/min (MDRD method or measured GFR) excluded
Liver function
Child's Class C Liver Disease or worse excluded; AST or ALT > 2.5x ULN unless liver metastases present (then up to 5x ULN allowed)
Cardiac function
NYHA grade III or IV heart failure excluded; symptomatic congestive heart failure, unstable angina, hypertension (>180/110), arrhythmia excluded
Creatinine clearance <50 mL/min... Serum albumin ≤ 3.0 g/dL unless prothrombin time is within the normal range. Liver dysfunction as evidenced by Child s Class C Liver Disease or worse... AST or ALT > 2.5x ULN unless liver metastases are present, in which case up to 5x ULN would be allowed. Hb < 8.0 g/dL; WBC < 2.0 x 10^9/L (or ANC < 1000); Platelets < 100 x 10^9/L. In participants with symptoms of congestive heart failure, NYHA classification of grade III or IV
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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