Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation Therapy

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT04082520
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Grade 1 Meningioma
  • Grade 2 Meningioma
  • Grade 3 Meningioma
  • Recurrent Meningioma
  • Unresectable Meningioma

Eligibility Criteria

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

Interventions

  • Gallium Ga 68-DOTATATE — RADIATION
    Given IV
  • Lutetium Lu 177 Dotatate — DRUG
    Given IV
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo PET/MRI
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/MRI
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Computed Tomography — PROCEDURE
    Undergo PET/CT and/or SPECT/CT
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Single Photon Emission Computed Tomography — PROCEDURE
    Undergo SPECT/CT

Study Details

This phase II trial studies how well lutathera works in treating patients with meningioma that cannot be treated with surgery (inoperable) and is growing, spreading, or getting worse (progressive) after external beam radiation therapy. Lutathera is a radioactive drug administered in the vein that is designed to target and kill tumor cells. The goal of this study is to determine whether this drug is safe and effective in treating meningiomas that progress after radiation treatment. WHO Grade I and Cohort WHO II/III cohorts will be evaluated.

Key Dates

Start date
Apr 14, 2020
Status verified
Apr 2026
Primary completion
Sep 4, 2027
Completion
Mar 4, 2032

Study Design

Enrollment
42 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (gallium Ga 68-DOTATATE PET/MRI, Lutathera)
    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 SPECT/CT dosimetry on study.

Primary Outcome Measure

Progression-free survival - 6 months [ Time Frame: At 6 months after starting treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Kenneth W. Merrell, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Mayo Clinic in Rochester· Rochester, MN

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