[177Lu]Lu-DOTATATE for Brain Tumor
(MOMENTUM-1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called [177Lu]Lu-DOTATATE, a type of targeted radiotherapy, to evaluate its effectiveness for people with progressive meningioma, a type of brain tumor. The study aims to compare this new treatment to the standard care patients usually receive. Participants may qualify if they have a diagnosed meningioma that recent brain scans show is worsening. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Is there any evidence suggesting that [177Lu]Lu-DOTATATE is likely to be safe for humans?
Research has shown that [177Lu]Lu-DOTATATE is generally safe for treating brain tumors such as intracranial meningioma. Patients with this condition usually tolerate it well, according to studies. For example, one study reported that [177Lu]Lu-DOTATATE did not cause serious side effects in patients with advanced intracranial meningioma. Additionally, this treatment has been used for other types of tumors and has maintained a good safety record. While minor side effects can occur, serious ones have been rare. Overall, the treatment appears promising for both its safety and effectiveness.12345
Why do researchers think this study treatment might be promising for brain tumors?
Researchers are excited about [177Lu]Lu-DOTATATE because it offers a novel approach to treating brain tumors by using targeted radiotherapy. Unlike standard care options, such as surgery, chemotherapy, and external beam radiation, which can affect healthy tissues, [177Lu]Lu-DOTATATE specifically targets tumor cells with a radioactive isotope, potentially minimizing damage to surrounding healthy brain tissue. This targeted action could improve effectiveness and reduce side effects, making it a promising option for patients with brain tumors.
What evidence suggests that [177Lu]Lu-DOTATATE might be an effective treatment for intracranial meningioma?
Research has shown that \[177Lu\]Lu-DOTATATE, which participants in this trial may receive, may help treat meningiomas, a type of brain tumor. One study found that 69% of patients with advanced meningioma did not see their condition worsen for at least six months, an improvement over past treatments. Another study showed that the treatment reduced tumor size by 25% in some patients. Additionally, a larger study with 42 patients found that the disease did not worsen in 57% of the cases. These findings suggest that \[177Lu\]Lu-DOTATATE could effectively control the growth of meningiomas.12367
Who Is on the Research Team?
Erik P Sulman, MD,PhD
Principal Investigator
NYU Langone Health
Sylvia C Kurz, MD, PhD
Principal Investigator
Yale University
Are You a Good Fit for This Trial?
This trial is for patients with a confirmed diagnosis of grade 1-3 meningioma, a type of brain tumor. They must have measurable disease progression on MRI scans and show significant growth or new lesions within the last 6 to 12 months. Participants also need to demonstrate positive uptake on PET-CT scans using a specific radiotracer.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either [177Lu]Lu-DOTATATE or standard of care therapy, with crossover to [177Lu]Lu-DOTATATE at progression
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- [177Lu]Lu-DOTATATE
Trial Overview
The study compares [177Lu]Lu-DOTATATE, a radiopharmaceutical drug, against standard treatments for recurrent meningioma. It's an open-label phase 2 trial where participants are randomly assigned to receive either the experimental drug or conventional therapy.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Study participants receive \[177Lu\]Lu-DOTATATE
Study participants receive Local Standard of Care (SOC) Therapy. Control Arm participants crossover to \[177Lu\]Lu-DOTATATE at progression
Find a Clinic Near You
Who Is Running the Clinical Trial?
RTOG Foundation, Inc.
Lead Sponsor
Novartis Pharmaceuticals
Industry Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD
Citations
[177Lu]Lu-DOTATATE for Recurrent Meningioma (LUMEN-1 ...
The primary efficacy endpoint is locally assessed progression-free survival according to Response Assessment in Neuro-Oncology MRI meningioma ...
2.
onclive.com
onclive.com/view/lutetium-lu-177-dotatate-shows-promise-in-advanced-intracranial-meningiomaLutetium Lu 177 Dotatate Shows Promise in Advanced ...
Lutetium Lu 177 dotatate achieved a 6-month PFS rate of 69% in advanced intracranial meningioma, surpassing historical benchmarks. The study ...
[177Lu]Lu-DOTATATE for Recurrent Meningioma (LUMEN-1 ...
A more than 25% reduction in [68Ga]Ga-DOTATATE PET was observed in 5 meningiomas and 2 patients. In 1 lesion, this corresponded to a more than ...
Efficacy of Intra-arterial [177Lu]Lu-DOTATATE monotherapy ...
The largest prospective study, which included 42 patients and had a median follow-up of 63 months, reported a disease control rate (DCR) of 57% ...
Radioligand therapies in meningioma: Evidence and future ...
One case report of [177Lu]Lu-DOTATATE treatment in meningioma showed improved tumor uptake compared to intravenous radionuclide treatment.60 ...
Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Adults with ...
Overall, [177Lu]Lu-DOTA-TATE offers encouraging antitumor activity (overall tumor response rates and disease control rates) across NET types.
Safety and Therapeutic Optimization of Lutetium-177 Based ...
This review will focus on several clinically tested and reported tailored approaches to enhance the risk–benefit trade-off of radioligand therapy.
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