RecruitingPhase 2interventionalRules rewrite

Phase 2: testing [177Lu]Lu-DOTATATE for Intracranial Meningioma

This is an open-label, multicenter, randomly assigned, phase 2 clinical study to measure the how well it works of \[177Lu\]Lu-DOTATATE in patients with progressive grade 1-3 intracranial meningioma.

Official registry: https://clinicaltrials.gov/study/NCT06955169 · RTOG Foundation, Inc. · enrollment listed as 130

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are [177Lu]Lu-DOTATATE, or Standard of Care treatments. The registry lists allocation as randomized. This is an open-label, multicenter, randomly assigned, phase 2 clinical study to measure the how well it works of \[177Lu\]Lu-DOTATATE in patients with progressive grade 1-3 intracranial meningioma.

They plan to enroll about 130 people at 18 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

MOMENTUM-1: A Multicenter, Randomized, Open-Label, Phase II Study of [177LU]LU-DOTATATE in Adults With Progressive Intracranial Grade 1-3 Meningioma

Interventions: [177Lu]Lu-DOTATATE, Standard of Care treatments

Primary outcome (registry wording): Progression Free Survival (PFS)

Who it is for (from inclusion criteria)

Ages 18 Years to any
STEP 1 REGISTRATION
Histologically confirmed diagnosis of WHO grade 1-3 meningioma
Disease progression following at least one prior surgical intervention (biopsy or resection) and at least one prior course of radiation
The patient is not considered a candidate for additional surgery and/or radiation or the patient has declined additional surgery and/or radiation
Progression of disease determined by local radiology review per current RANO meningioma criteria, defined as:
≥ 15% increase in sum of product of perpendicular measurements of up to 5 measurable target lesions within the last 6 months (196 days), or
≥ 25% increase in sum of product of perpendicular measurements of up to 5 measurable target lesions within the last 12 months (379 days), or

Who the registry excludes

Patients with a clinical diagnosis of NF2-related schwannomatosis or with a known molecular diagnosis of NF2-related schwannomatosis
Patients with radiation-associated meningiomas
Patients with known intraspinal meningiomas or meningioma metastases outside the skull/spinal column. Meningiomas invading the skull base or orbits are not excluded
Prior SSTR2-targeted therapy, e.g. Somatostatin LAR or short-acting Octreotide. No limit on number of prior non-SSTR2-tartgeted systemic therapies
Unstable neurological symptoms requiring steroids to control symptoms at a dose of \>2 mg of dexamethasone (or equivalent) daily within 28 days prior to step 2 registration
Patients requiring immediate local therapy (e.g. surgical resection)
Surgical procedure within the timeframes listed below, prior to step 2 registration

Public study contact (from the registry)

Sylvia C Kurz, MD,PhD

203-785-5616

Sylvia.Kurz@yale.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

18 listed

University of California, Irvine — Irvine, California (recruiting)
University of California San Diego - Moores Cancer Center — La Jolla, California (recruiting)
Yale University — New Haven, Connecticut (recruiting)
Baptist MD Anderson Cancer Center — Jacksonville, Florida (recruiting)
University of Miami — Miami, Florida (recruiting)
Baptist Health Medical Group Oncology — Miami, Florida (recruiting)
Moffitt Cancer Center — Tampa, Florida (recruiting)
Piedmont Healthcare — Atlanta, Georgia (recruiting)
Indiana University — Indianapolis, Indiana (recruiting)
University of Iowa Health Care — Iowa City, Iowa (recruiting)
Dana-Farber/Harvard Cancer Center — Boston, Massachusetts (recruiting)
University of Michigan Rogel Cancer Center — Ann Arbor, Michigan (recruiting)

Related recruiting trials in this snapshot

RecruitingNot a traditional drug phaseBethesda, Maryland

Von Hippel-Lindau (VHL): Clinical Manifestations, Diagnosis, Management and Molecular Bases of Inherited Re…

We will investigate the clinical manifestations and molecular genetic defects of heritable urologic malignant disorders. Families with urologic malignancy with known or suspected genetic basis will be enrolled.

NCT00001238 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

RecruitingNot a traditional drug phaseBethesda, Maryland

Study of Systemic Lupus Erythematosus

This protocol will evaluate patients with systemic lupus erythematosus (SLE) and their relatives to learn more about how the disease develops and changes over time. It will also study genetic factors that make a person susceptible to SLE.

NCT00001372 · Official ClinicalTrials.gov record · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

RecruitingNot a traditional drug phaseWashington D.C., District of Columbia

Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics

This study is designed to explore the genetics and pathophysiology of diseases presenting with intermittent fever, including familial Mediterranean fever, TRAPS, hyper-IgD syndrome, and related diseases. The following individuals may be eligible for this natural history study: 1) patients with known or suspected familial Mediterranean fever, TRAPS, hyper-IgD syndrome or related disorders; 2) relatives of these patients; 3) healthy, normal volunteers 7 years of age or older.

NCT00001373 · Official ClinicalTrials.gov record · National Human Genome Research Institute (NHGRI)

FAQ about this NCT record

Is NCT06955169 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06955169?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06955169?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary