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Radioisotope Therapy
Lutathera for Pheochromocytoma/Paraganglioma
Phase 2
Recruiting
Led By Frank I Lin, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Surgically inoperable participants with clinical diagnosis of PHEO/PGL with demonstrated disease histologically consistent with pheochromocytoma or paraganglioma
Ineligible, unable to, or unwilling to receive standard first-line therapy for PHEO/PGL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial is testing a new drug, Lu-177-DOTATATE, to see if it is safe and effective in treating rare tumors.
Who is the study for?
Adults with inoperable pheochromocytoma or paraganglioma that shows up on a Ga-68-DOTATATE PET/CT scan. They should have progressive disease, no severe liver or kidney issues, and not be pregnant. Participants must agree to use non-hormonal contraception for 6 months post-treatment if of childbearing potential.Check my eligibility
What is being tested?
The trial is testing Lu-177-DOTATATE's safety and effectiveness against rare tumors near the adrenal gland or neck region. Patients receive four intravenous doses about eight weeks apart, followed by scans and regular check-ups including quality of life assessments over three years.See study design
What are the potential side effects?
Possible side effects include nausea, vomiting, fatigue, blood cell count changes leading to increased infection risk, kidney damage, and potentially allergic reactions to the infusion. Long-term risks may involve bone marrow suppression and secondary cancers.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor is a pheochromocytoma or paraganglioma and cannot be removed with surgery.
Select...
I cannot or do not want to receive standard treatment for my PHEO/PGL.
Select...
My tumor is not linked to genetic mutations, except for SDHx.
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I am 18 years old or older.
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I can care for myself but may not be able to do active work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
progression-free survival
Secondary outcome measures
Determine ability to decrease anti-hypertensive medication
Determine changes in plasma biochemical markers
Evaluate Quality of Life
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: 1/Lu-177-DOTATATEExperimental Treatment4 Interventions
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.
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Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,658 Previous Clinical Trials
40,924,457 Total Patients Enrolled
78 Trials studying Neuroendocrine Tumors
43,533 Patients Enrolled for Neuroendocrine Tumors
Frank I Lin, M.D.Principal InvestigatorNational Cancer Institute (NCI)
1 Previous Clinical Trials
42 Total Patients Enrolled
1 Trials studying Neuroendocrine Tumors
42 Patients Enrolled for Neuroendocrine Tumors
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have no other cancers except for non-melanoma skin cancer or cervical carcinoma in situ.My kidney function is reduced with a creatinine clearance below 50 mL/min.My liver function is severely impaired.My heart failure is severe, making daily tasks very difficult.I have had cancer treatment with radioactive materials.My brain metastases have been treated and stable for at least 6 months.I haven't started or changed my somatostatin treatment in the last 3 months.I do not have any uncontrolled illnesses.My tumor is a pheochromocytoma or paraganglioma and cannot be removed with surgery.My scan shows I have SSTR+ disease.I cannot or do not want to receive standard treatment for my PHEO/PGL.I am 18 years old or older.I cannot tolerate certain types of body scans.My cancer has worsened in the last year according to scans.My tumor is not linked to genetic mutations, except for SDHx.I can care for myself but may not be able to do active work.I can understand and am willing to sign the informed consent.I am on medication to manage hormone release from my tumor.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In what therapeutic treatments is Lu-177-DOTATATE most commonly incorporated?
"Lu-177-DOTATATE is the go to treatment for neuroendocrine tumours. This medication also has potential applications in treating parenteral nutrition, pregnancy delivery, and uremia."
Answered by AI
Is this research endeavor actively seeking participants?
"Affirmative. According to information on clinicaltrials.gov, this trial has been open for recruitment since October 10th 2017 and its most recent update was made on October 4th 2022. 90 participants are expected from 1 medical centre."
Answered by AI
Has Lu-177-DOTATATE been sanctioned by the FDA?
"Although there is no data currently available to support the efficacy of Lu-177-DOTATATE, Phase 2 trials have provided evidence indicating its safety. This led our team at Power to assign it a score of 2 on their scale of 1 - 3."
Answered by AI
Are there any related investigations dealing with Lu-177-DOTATATE?
"Presently, 47 studies utilizing Lu-177-DOTATATE are live with 4 trials in the third phase. A number of these experiments can be found in Bethesda, Maryland while 301 different locations host research on this monoclonal antibody across various parts of the globe."
Answered by AI
How many participants have registered for this experiment?
"Affirmative. According to the clinicaltrials.gov page for this trial, it is actively recruiting participants who meet its criteria; first posted on October 10th 2017 and most recently edited on October 4th 2022. 90 individuals from a single medical centre are required to complete the study."
Answered by AI
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