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Radioisotope Therapy
Lutathera for Meningioma
Phase 2
Recruiting
Led By Erik Sulman, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female subjects aged ≥ 18 years
Histologically confirmed diagnosis WHO grade I-III meningioma with specific criteria for each grade
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years post treatment
Awards & highlights
Study Summary
This trial will test whether Lutathera is effective in treating meningioma. Lutathera will be given intravenously every 8 weeks for 4 doses, and PET-MRI scans will be done before treatment and 6 months after the start of treatment.
Who is the study for?
Adults with progressive or high-risk meningioma who show positive uptake on PET-MRI scans and have tumors expressing SSTR2. Participants must be over 18, able to undergo regular MRI scans, have stable neurological symptoms for at least a month before joining, and good organ function. They should not be pregnant, breastfeeding, or have had certain other treatments like peptide receptor radionuclide therapy.Check my eligibility
What is being tested?
The trial is testing Lutathera (177Lu-DOTATATE), given intravenously every two months for four doses total. Patients will get PET-MRI scans before starting treatment and six months after to see how effective the drug is against meningioma that lights up on these special scans.See study design
What are the potential side effects?
Possible side effects of Lutathera may include nausea, vomiting, fatigue, low blood cell counts leading to increased infection risk or bleeding problems, liver toxicity, kidney damage including renal failure in severe cases and hormonal gland dysfunction.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My meningioma is confirmed and graded I-III by a doctor.
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I can care for myself but may need occasional help.
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My latest tumor test shows positive for SSTR2.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years post treatment
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 at 6 months (PFS-6)
Secondary outcome measures
Objective Response Rate (ORR)
Overall Survival (OS)
Overall Survival at 12 months (OS-12)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: LutatheraExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,367 Previous Clinical Trials
839,689 Total Patients Enrolled
1 Trials studying Meningioma
5 Patients Enrolled for Meningioma
Erik Sulman, MDPrincipal InvestigatorNew York Langone Health
1 Previous Clinical Trials
10 Total Patients Enrolled
Sylvia Kurz, MDPrincipal InvestigatorNYU Langone Health
2 Previous Clinical Trials
16 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic to somatostatin analogues or components in 68Ga-DOTATATE or 177Lu-DOTATATE treatments.I am currently on IV antibiotics for an infection.There is a sample of your tumor tissue preserved in wax or on slides for review by a pathologist.I am 18 years old or older.My organs and bone marrow are working well.I have been diagnosed with NF2.My meningioma is confirmed and graded I-III by a doctor.You have a positive result for 68Ga-DOTATATE uptake on PET-MRI.My neurological symptoms have not changed in the last 28 days.I have had multiple treatments, including surgery and radiation, for my condition.You have at least one tumor that is at least 10 millimeters in size when measured with a special kind of MRI scan.I have another cancer that is getting worse or needs treatment.You are currently taking any other experimental medication for your main cancer.I have had peptide receptor radionuclide therapy before.I have not had severe medical or mental health issues in the past year.I have a brain tumor linked to past radiation treatment.I can care for myself but may need occasional help.My latest tumor test shows positive for SSTR2.I do not have any uncontrolled illnesses like heart disease or active HIV/HBV/HCV.I have recovered from major side effects of my previous treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Lutathera
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.
Could you expound on the security of Lutathera for humans?
"Our evaluation at Power rated Lutathera's safety a 2, as there are some clinical data that suggest its safety but none indicating efficacy."
Answered by AI
Has the efficacy of Lutathera been examined by other research groups?
"At present, 23 studies of Lutathera are being performed. One is in the concluding Phase 3 stage while most are located at Iowa City, IA with 162 sites across the USA administering this drug."
Answered by AI
What is the enrollment size for this research endeavor?
"Indeed, according to clinicaltrials.gov's records, this study is recruiting patients and was initially posted on May 15th 2019. The trial has been recently modified as of September 13th 2022 and aims to enroll 32 people at 2 locations."
Answered by AI
Is enrollment for this research endeavor currently open?
"Indeed, clinicaltrials.gov shows that this trial is actively searching for participants to join the study. The initial posting was on May 15th 2019 and it has been last edited on September 13th 2022. 32 volunteers are sought after between two sites."
Answered by AI
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