Recruiting
Phase 2

Lu-177-DOTATATE

Sponsor:

National Cancer Institute (NCI)

Code:

NCT03206060

Conditions

Pheochromocytoma

Paraganglioma

Neuroendocrine Tumors

Neuroendocrine Neoplasms

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Lu-177-DOTATATE

Ga-68-DOTATATE

Study Details

Brief 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.

Conditions

Pheochromocytoma

Paraganglioma

Neuroendocrine Tumors

Neuroendocrine Neoplasms

Study ID

NCT03206060

Start date

Oct 10, 2017

Status verified date

Aug 19, 2026

Completion date

Jan 1, 2033

Anticipated

Primary completion date

Jan 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • INCLUSION CRITERIA:
  • Surgically inoperable participants with clinical diagnosis of PHEO/PGL who also have demonstrated disease histologically consistent with pheochromocytoma or paraganglioma (preferably confirmed by research site pathology review if initial pathology was done outside of research site, but not mandatory)
  • Progressive disease by RECIST 1.1 with or without symptoms within the last 12 months. NOTE: Untreated participants with existing histologic diagnoses are eligible if progression can be demonstrated
  • 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. PHEO/PGL that is associated with non-SDHx mutations such as VHL, NF1, and RET will not be eligible for this study.
  • Both metastatic and inoperable primary-only participants are eligible.
  • Must have presence of SSTR+ disease as documented by positive Ga-68-DOTATATE PET scan within 12 weeks of anticipated treatment.

NOTE:

  • Positivity of Ga-68-DOTATATE PET scan defined as having at least one lesion that is greater than or equal to 10 mm in diameter with uptake that is higher than or equal to liver and is qualitatively higher and distinguishable from background activity.
  • Measurable disease as defined by RECIST 1.1.

  • Age greater than or equal to 18
  • Karnofsky Performance Score greater than or equal to 60 or ECOG Performance Status of 2 or better.
  • Able to understand and willing to sign informed consent.
  • Ability and willingness to obtain all required scans per study schedule.
  • Negative serum pregnancy test for women of child-bearing potential. NOTE: A female is not of childbearing potential if a prior history of hysterectomy with bilateral oophorectomy or other procedure has rendered the participant surgically sterile, or >2 years since last menstruation.
  • Female participants of childbearing potential and male participants who are not surgically sterile or with female partners of childbearing potential must agree to use effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal gel) prior to study entry, for the duration of study participation, and for 4 months for male participants or 7 months for female participants (10 half-lives of Lu-177) after the last dose of Lu-177-DOTATATE.
  • Must have outside endocrinologist/medical oncologist who can follow the participant after receiving PRRT (NIH only requirement).
  • Patients with secreting tumors must be receiving adequate pharmacologic catecholamine blockade as determined by the treating physician.
  • Ineligible, unable to or unwilling to receive standard first line therapy for PHEO/PGL.

EXCLUSION CRITERIA:

  • Creatinine clearance <50 mL/min calculated by the MDRD method, eventually confirmed by measured creatinine clearance (or measured glomerular filtration rate (GFR) using plasma clearance methods.
  • Serum albumin less than or equal to 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 Alternatively, AST or ALT > 2.5 times institutional upper limit of normal (ULN) unless liver metastases are present, in which case up to 5 times ULN would be allowed.
  • Hb < 8.0 g/dL; WBC < 2.0 x 10\^9/L (or Absolute Neutrophil Count < 1000); Platelets < 100 x 10\^9/L
  • In participants with symptoms of congestive heart failure, New York Heart Association (NYHA) classification of grade III or IV
  • Pregnancy or lactation.
  • Prior anti-tumoral radionuclide therapy with unsealed sources. Prior therapy with sealed radioactive sources such as brachytherapy will be allowed.
  • Prior local radiation therapy would be allowed as long as there is at least one non-irradiated index lesion.
  • Known brain metastases, unless these metastases have been treated and stabilized for at least 24 weeks, prior to enrollment in the study. Patients with a history of brain metastases must have a head CT or MRI scan with contrast to document stable disease for at least 24 weeks prior to enrolment in the study.
  • Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and proven no evidence of recurrence for 5 years.
  • Patients who participated in any therapeutic clinical study with an investigational agent within the last 30 days.
  • Patients may be on somatostatin analogue therapy (e.g. but not only limited to sandostatin or lanreotide therapy). However, therapy with somatostatin analogues should not be initiated or altered within 3 months of study enrolment. Patients on short term octreotide may have dose held for 24 hours prior to Lu-177-DOTATATE therapy. Those on long acting octreotide therapy will receive treatment at 1 to 5 days prior to their next cold octreotide dose, in order to prevent competition for the receptor.
  • Patient weight > 400 lbs (table limit for PET scanner) or per local institutional standard for participating sites.
  • Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, hypertension (>180/110), arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Inability to tolerate at least one modality of diagnostic anatomic imaging, such as CT or MRI.

Study Design

Enrollment

130 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1/Lu-177-DOTATATE

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.

Interventions

Lu-177-DOTATATE

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

Ga-68-DOTATATE

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

Primary outcome measure

  • progression-free survival [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Joy H Zou, R.N.

(240) 760-6153joy.zou@nih.gov

Frank I Lin, M.D.

(240) 760-6166frank.lin2@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

National Cancer Institute Referral Office

888-624-1937

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Aug 25, 2026

Last verified

Aug 19, 2026

Keywords

  • Hypertension
  • Catecholamine
  • Familial Syndromes
  • Somatostatin Receptors
  • Ionizing Radiation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-08-25.