Comparing the Radiopharmaceutical Drug, [177Lu]Lu-DOTATATE, to Standard of Care Treatment for Patients With Meningioma That Has Come Back After Prior Treatment

Part of paid clinical trials in Irvine, California.

Sponsor
RTOG Foundation, Inc.
Study ID
NCT06955169
Phase
PHASE2
Status
Recruiting
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Conditions

  • Intracranial Meningioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • [177Lu]Lu-DOTATATE — DRUG
    The treatment regimen consists of 4 (+2 optional) administrations of \[177Lu\]Lu-DOTATATE. The recommended interval between infusions is 4 weeks (+ 7 days).
  • Standard of Care treatments — OTHER
    Treatments will occur at the discretion and based on clinical judgement of the local and treating investigator. Systemic SOC therapy with one of the following agents: bevacizumab, everolimus, or sunitinib.

Study Details

This is an open-label, multicenter, randomized, phase 2 clinical study to evaluate the efficacy of \[177Lu\]Lu-DOTATATE in patients with progressive grade 1-3 intracranial meningioma.

Key Dates

First listed
May 2, 2025
Start date
Aug 24, 2025
Status verified
Sep 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2030

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: [177Lu]Lu-DOTATATE
    Study participants receive \[177Lu\]Lu-DOTATATE
  • Other: Control
    Study participants receive systemic Standard of Care (SOC) Therapy. Control Arm participants crossover to \[177Lu\]Lu-DOTATATE at progression

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Assessed up to 4 years ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
University of California, IrvineIrvineCalifornia92697
Manisha Dandekar
[email protected]
Daniela Bota, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of California San Diego - Moores Cancer CenterLa JollaCalifornia92093
Mohammad Amjad
[email protected]
Jona Hattangadi-Gluth, MD (PRINCIPAL_INVESTIGATOR)
Yale UniversityNew HavenConnecticut06520
Amy Rodrigues, CCRC
[email protected]
203-260-9632
Sylvia Kurz, MD, PhD (PRINCIPAL_INVESTIGATOR)
Baptist MD Anderson Cancer CenterJacksonvilleFlorida32207
Michael Olson, MD PhD (PRINCIPAL_INVESTIGATOR)
Andre Alvarez, MD PhD (SUB_INVESTIGATOR)
Baptist Health Medical Group OncologyMiamiFlorida33176
Nicolas Morales
[email protected]
Matthew Hall, MD (PRINCIPAL_INVESTIGATOR)
University of MiamiMiamiFlorida33146
Lily Friedman
[email protected]
Marina Kushnirsky, MD (PRINCIPAL_INVESTIGATOR)
Moffitt Cancer CenterTampaFlorida33543
Abdullah Abdelkawy
[email protected]
Andre Luiz Beer Furlan, MD, PhD (PRINCIPAL_INVESTIGATOR)
Piedmont HealthcareAtlantaGeorgia30318
Jeff Whorton, BSN,RN
[email protected]
Adam Nowlan, MD, MPH (PRINCIPAL_INVESTIGATOR)
Indiana UniversityIndianapolisIndiana46202
Lauren Perrey-Moore, RN
[email protected]
Kathryn Nevel, MD (PRINCIPAL_INVESTIGATOR)
University of Iowa Health CareIowa CityIowa52242
Kristin West, RN, BSN
[email protected]
Kristin Plichta, MD, PhD (PRINCIPAL_INVESTIGATOR)
Dana-Farber/Harvard Cancer CenterBostonMassachusetts02215
Kathryn Partridge
[email protected]
Gilbert Youssef, MD (PRINCIPAL_INVESTIGATOR)
University of Michigan Rogel Cancer CenterAnn ArborMichigan48109
Sean Miller, MD (PRINCIPAL_INVESTIGATOR)
NYU Lagone HealthNew YorkNew York10016
Olga Garduno-Ortega
[email protected]
Marissa Barbaro, MD (PRINCIPAL_INVESTIGATOR)
Duke University Medical CenterDurhamNorth Carolina22708
Kelly Moulton
[email protected]
Margaret Johnson, MD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Wathoo Chetna
[email protected]
Carlos Kamiya-Matsuoka, MD (PRINCIPAL_INVESTIGATOR)
Medical College of WisconsinMilwaukeeWisconsin53226
Bailee Fritz
[email protected]
Michael Straza, MD (PRINCIPAL_INVESTIGATOR)

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