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Radioisotope Therapy
Lutathera for Meningioma
Phase 2
Waitlist Available
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
Must not have
Known hypersensitivity to somatostatin analogues or any component of the 68Ga- DOTATATE or 177Lu-DOTATATE formulations
Active infection requiring intravenous therapy with antibiotics
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years post treatment
Awards & highlights
Summary
This trial tests Lutathera, a targeted radiation therapy given through an IV, in patients with certain types of growing or high-risk brain tumors. The treatment aims to destroy tumor cells using targeted radiation.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am allergic to somatostatin analogues or components in 68Ga-DOTATATE or 177Lu-DOTATATE treatments.
Select...
I am currently on IV antibiotics for an infection.
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I have been diagnosed with NF2.
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I have another cancer that is getting worse or needs treatment.
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I have had peptide receptor radionuclide therapy before.
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I have a brain tumor linked to past radiation treatment.
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I do not have any uncontrolled illnesses like heart disease or active HIV/HBV/HCV.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression Free Survival at 6 months (PFS-6)
Secondary study objectives
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lutathera
2022
N/A
~90
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Lutathera (177Lu-DOTATATE) is a radiolabeled somatostatin analog that binds to somatostatin receptors on meningioma cells, delivering targeted radiation to kill the cancer cells. This targeted approach minimizes damage to surrounding healthy tissue, making it a valuable option for patients with somatostatin receptor-positive tumors.
Other common treatments for meningioma include surgery, which physically removes the tumor; radiation therapy, which uses high-energy rays to destroy cancer cells; and chemotherapy, which uses drugs to kill rapidly dividing cells. Each treatment has its own mechanism and is chosen based on the tumor's characteristics and patient-specific factors, aiming to maximize efficacy while minimizing side effects.
Management of a Patient With Metastatic Gastrointestinal Neuroendocrine Tumor and Meningioma Submitted to Peptide Receptor Radionuclide Therapy With 177 Lu-DOTATATE.Neuroendocrine tumor theranostics.Extraventricular neurocytoma treated with 177Lu DOTATATE PRRT induction and maintenance therapies.
Management of a Patient With Metastatic Gastrointestinal Neuroendocrine Tumor and Meningioma Submitted to Peptide Receptor Radionuclide Therapy With 177 Lu-DOTATATE.Neuroendocrine tumor theranostics.Extraventricular neurocytoma treated with 177Lu DOTATATE PRRT induction and maintenance therapies.
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,397 Previous Clinical Trials
861,133 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
3 Previous Clinical Trials
62 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.
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