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Radioactive Drug
Lutathera for Progressive Meningioma
Phase 2
Recruiting
Led By Kenneth W Merrell
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Willing to undergo 68Ga-DOTATATE PET imaging. 68Ga-DOTATATE PET imaging must be Krenning score must be a score of 2 or higher, suggesting somatostatin receptor expression, to be enrolled on the study
Radiographic evidence of meningioma progression with measurable disease, defined as an increase in size of the measurable primary lesion on imaging by 15% or more (sum of the bidirectional measurements) in an approximate 6 month time period (i.e., calculated rate of growth 15% / 6 months based on available scans) or by the appearance of a new measurable lesion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing a radioactive drug to see if it is safe and effective in treating meningiomas that have progressed after radiation treatment.
Who is the study for?
This trial is for adults with inoperable, progressive meningioma after radiation therapy. They must have had prior treatments like surgery if possible, show tumor growth on scans, and not be candidates for more radiotherapy. Participants need to have a certain level of physical fitness (ECOG PS <=2), adequate organ function, and agree to use contraception if applicable.Check my eligibility
What is being tested?
The trial tests Lutathera's effectiveness and safety in treating meningiomas that worsen post-radiation. It involves radioactive drug infusion targeting cancer cells, alongside assessments through questionnaires, quality-of-life measures, MRI scans, and PET imaging using Gallium Ga 68-DOTATATE.See study design
What are the potential side effects?
Potential side effects include reactions related to the infusion of a radioactive substance such as nausea or vomiting; blood count changes; kidney dysfunction; liver enzyme alterations; fatigue; allergic responses; and possibly others based on individual health conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to a 68Ga-DOTATATE PET scan and my scan shows a Krenning score of 2 or higher.
Select...
My meningioma has grown by 15% or more in the last 6 months.
Select...
I've had radiation for meningioma but can't safely have more.
Select...
I can take care of myself but might not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 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
Incidence of adverse events
Overall survival
Progression free survival
Other outcome measures
Change in quality of life (QOL)
Duration of local control
Local control
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (gallium Ga 68-DOTATATE PET/MRI, Lutathera)Experimental Treatment8 Interventions
Patients receive gallium Ga 68-DOTATATE IV and undergo a PET/MRI or PET/CT before cycles 1 and 4. Patients then receive lutetium Lu 177 dotatate IV over 30-40 minutes. Treatment repeats every 8 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo MRI on study and during follow-up, as well as blood sample collection and possible SEPCT/CT dosimetry on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1700
Positron Emission Tomography
2008
Completed Phase 2
~2240
Gallium Ga 68-DOTATATE
2018
Completed Phase 2
~30
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Computed Tomography
2017
Completed Phase 2
~2720
Single Photon Emission Computed Tomography
2008
Completed Phase 4
~310
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,813 Total Patients Enrolled
45 Trials studying Meningioma
4,196 Patients Enrolled for Meningioma
Mayo ClinicLead Sponsor
3,212 Previous Clinical Trials
3,766,997 Total Patients Enrolled
1 Trials studying Meningioma
7 Patients Enrolled for Meningioma
Kenneth W MerrellPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your hemoglobin level should be at least 9.0 grams per deciliter.You have a disease that can be measured or seen by the doctor.I agree to a 68Ga-DOTATATE PET scan and my scan shows a Krenning score of 2 or higher.I am not on any experimental drugs for my cancer.I have a tumor in the covering of my optic nerve or outside my brain.I am of childbearing age and do not plan to use birth control.My kidney function, measured by creatinine clearance, is good.I have not had any other cancer within the last 2 years.I have been treated for meningioma, possibly including surgery and radiation.Your bilirubin levels in your blood should not be too high, unless you have a condition called Gilbert's syndrome.My meningioma has grown by 15% or more in the last 6 months.Women who can have babies need to have a negative pregnancy test within 7 days before joining the study.My blood clotting tests are normal or managed if I'm on blood thinners.I am currently breastfeeding.I've had radiation for meningioma but can't safely have more.Your white blood cell count needs to be above a certain level, which will be checked within the 14 days before you join the study.I can take care of myself but might not be able to do heavy physical work.I am immunocompromised or HIV positive and on antiretroviral therapy.I have had serious side effects from previous radiation therapy.I am eligible for surgery or radiation aimed at curing my condition.I cannot undergo MRI due to health reasons or past bad reactions.I do not have any severe illnesses that my doctor says could interfere with the study.I have had a heart attack in the last 6 months or have heart failure needing ongoing treatment.Your liver enzyme levels are not more than three times the normal limit.I cannot control my bladder, which may affect my treatment safety.Your platelet count must be at least 100,000 per millimeter, as measured within the last 14 days before joining the study.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (gallium Ga 68-DOTATATE PET/MRI, 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.
What other experiments have been done to explore the potential of Lutetium Lu 177 Dotatate?
"Presently, 23 clinical trials of Lutetium Lu 177 Dotatate are underway, with 1 in its final Phase 3. Out of 162 total sites participating in these studies, the majority are based out of Iowa City, IA."
Answered by AI
Are there any opportunities to join this experiment at the moment?
"This clinical study is actively recruiting as indicated on clinicaltrials.gov; the initial posting was made on March 10th 2020, with a recent update being applied on May 10th 2022."
Answered by AI
What is the current enrollment count for this research?
"Absolutely. The records on clinicaltrials.gov demonstrate that this medical trial, which was first published on 10th March 2020, is actively enrolling participants. A total of 41 patients must be found from a single site to complete the study."
Answered by AI
Could you provide an assessment of the safety profile for Lutetium Lu 177 Dotatate?
"Our team assessed the safety of Lutetium Lu 177 Dotatate as a 2, due to its Phase 2 status. This indicates that there is only some data demonstrating it's security with no information on efficacy yet available."
Answered by AI
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