Lu-177-DOTATATE (Lutathera) in Therapy of Inoperable Pheochromocytoma/ Paraganglioma
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|ClinicalTrials.gov Identifier: NCT03206060|
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : September 25, 2020
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.
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.
Adults who have an inoperable tumor of the study cancer that can be detected with Ga-68-DOTATATE PET/CT imaging
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.
|Condition or disease||Intervention/treatment||Phase|
|Pheochromocytoma Paraganglioma Neuroendocrine Tumors Neuroendocrine Neoplasms||Drug: Lu-177-DOTATATE Drug: Ga-68-DOTATATE Drug: F-18-FDG Drug: Amino Acid solution||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Lu-177-DOTATATE (Lutathera) in Therapy of Inoperable Pheochromocytoma/ Paraganglioma|
|Actual Study Start Date :||October 10, 2017|
|Estimated Primary Completion Date :||January 1, 2023|
|Estimated Study Completion Date :||January 1, 2025|
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.
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
F-18-FDG PET/CT at weeks 15 and 31, every 24 weeks during 3 years follow up period
Drug: Amino Acid solution
AA solution will be administered 60 minutes prior to each Lu-177- DOTATATE infusion.
- progression-free survival [ Time Frame: 6 months ]Median amount of time subject survives without disease progression after treatment
- safety and tolerability profile [ Time Frame: 30 days after the last dose study drug ]List of adverse event frequency
- Determine ability to decrease anti-hypertensive medication [ Time Frame: 3 years ]Proportion of patients using decreased amount of antihypertensivemedication
- Evaluate Quality of Life [ Time Frame: 3 years ]Proportion of patients with increased Quality of Life (QoL)
- Determine changes in plasma biochemical markers [ Time Frame: 3 years ]changes in plasma biochemical markers
- Time to tumor progression [ Time Frame: at disease progression ]Median amount of time subject survives without disease progression after treatment
- Objective response rate [ Time Frame: at disease progression ]Proportion of patients whose tumors shrunk after therapy
- Overall survival [ Time Frame: at death ]Median amount of time subject survives after therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03206060
|Contact: Joy Zou, R.N.||(240) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Frank I Lin, M.D.||National Cancer Institute (NCI)|