Lu-177-DOTATATE (Lutathera) in Therapy of Inoperable Pheochromocytoma/ Paraganglioma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-100
SponsorNational Cancer Institute (NCI)
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Lu-177-DOTATATE
DrugLu-177-DOTATATE IV at weeks 1, 8, 16 and 24.
Ga-68-DOTATATE
DrugGa-68-DOTATATE PET/CT at weeks 15 and 31, every 24 weeks during 3 years follow up period.
Treatment groups
130 Participants
are divided into 1 treatment groupGroup A: 1/Lu-177-DOTATATEExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
progression-free survival
Median amount of time subject survives without disease progression after treatment
Time frame
6 monthsSecondary outcomes
1
Time to tumor progression
Median amount of time subject survives without disease progression after treatment
Time frame
at disease progression2
Safety and tolerability profile
List of adverse event frequency
Time frame
30 days after the last dose of study drug3
Overall survival
Median amount of time subject survives after therapy
Time frame
at death4
Objective response rate
Proportion of patients whose tumors shrunk after therapy
Time frame
at disease progressionSponsors and contacts
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Source ClinicalTrials.gov