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Trial record 2 of 2 for:    Recruiting, Enrolling by invitation Studies | Interventional Studies | meningioma | United States | First posted from 04/01/2019 to 07/31/2019

Phase II Study of 177Lu-DOTATATE Radionuclide in Adults With Progressive or High-risk Meningioma

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ClinicalTrials.gov Identifier: NCT03971461
Recruitment Status : Recruiting
First Posted : June 3, 2019
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
This single arm, open-label study will evaluate the efficacy of Lutathera (177Lu-DOTATATE) administered intravenously every 8 weeks for a total of 4 doses in patients with progressive WHO I-III or residual high-risk Ga-DOTATATE PET-MRI positive meningioma. Ga-DOTATATE PET-MRI scans will be obtained prior to initiation of Lutathera treatment and 6 months after the initiation of Lutathera treatment. The latter will be performed within the 14 days prior to the last dose of Lutathera treatment.

Condition or disease Intervention/treatment Phase
Meningioma Drug: Lutathera Phase 2

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Study Type : Interventional
Estimated Enrollment : 32 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open-label, single arm, multicenter, two-stage phase 2 clinical study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Arm, Open-label, Multicenter Phase II Study of 177Lu-DOTATATE Radionuclide in Adults With Progressive or High-risk Meningioma
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lutathera Drug: Lutathera
administered intravenously every 8 weeks for a total of 4 doses
Other Name: 177Lu-DOTATATE




Primary Outcome Measures :
  1. Progression Free Survival at 6 months (PFS-6) [ Time Frame: 6 Months ]
    proportion of subjects who achieve a complete response (CR), partial response (PR), or stable disease (SD) at 6 months from start of Lutathera treatment. Radiographic treatment response will be assessed by measuring the bidirectional tumor diameters on contrast-enhanced MRI in patients who received at least one dose of Lutathera compared to baseline measurements at time of study enrollment


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: 12 months ]
    defined as the best response [Complete Response (CR) + Partial Response (PR) + stable disease (SD)] recorded from the start of the study until the end of study in patients who received at least one dose of Lutathera.

  2. Overall Survival at 12 months (OS-12) [ Time Frame: 12 months ]
    proportion of subjects who are alive at 12 months from start of Lutathera treatment. Survival data will be captured by clinical follow-up every 8 weeks during treatment with Lutathera and by follow-up phone calls every 12 weeks for up to 2 years after completion of treatment with Lutathera.

  3. Progression Free Survival (PFS) [ Time Frame: 2 Years Post Treatment ]
    defined as the number of days from the treatment start date to the date of documented disease progression or death due to any cause.

  4. Overall Survival (OS) [ Time Frame: 2 Years Post Treatment ]
    defined as the number of days from the treatment start date to the date of death due to any cause.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Karnofsky Performance Status ≥ 60.
  • Histologically confirmed diagnosis WHO grade I-III meningioma:
  • For grade I meningioma, subjects must have:
  • Progressive disease after at least surgical resection and radiotherapy, as defined as an increase in size of the measurable primary lesion (bidirectional area) on imaging by 25% or more between scans separated by no more than 24 months.
  • Progressive residual tumor after maximal safe resection, be located at or near critical organs at-risk [24] and considered to be high-risk for radiation injury by the treating investigator. Prior external beam radiotherapy is not required for these subjects.
  • For Grade II or III meningioma, subjects must have either:
  • Progressive disease after at surgical resection and radiotherapy, as defined as an increase in size of the measurable primary lesion (bi-directional area) on imaging by 25% or more between scans separated by no more than 24 months
  • Residual measurable disease after surgery without requirement of progression.
  • Positive 68Ga-DOTATATE uptake on PET-MRI.
  • Positive uptake is defined as uptake higher than the background and SUV ratios adjusted to the liver and spleen uptake (adopted from Krenning score).25
  • Presence of measurable disease defined as at least one lesion measuring ≥10 mm in at least one dimension by contrast-enhanced MRI performed within 30 days prior to study registration.
  • Multifocal disease, meningioma with extra-cranial spread, spinal meningiomas, and metastatic meningiomas (as defined by extracranial meningiomas) are allowed.
  • There is no limit on the number of prior surgeries, radiation therapy, radiosurgery treatments or systemically administered therapeutic agents.
  • For patients treated with external beam radiation, interstitial brachytherapy or radiosurgery, an interval ≥24 weeks must have elapsed from completion from these therapies to registration unless there is histopathologic confirmation of recurrent tumor or there is new enhancing tumor outside the radiation field (beyond the high dose region or the 80% isodose line).
  • An interval of ≥28 days (or 5 half-lives, whichever is shorter) from prior cytotoxic chemotherapy (6 weeks from nitrosoureas), biologic agent, investigational agent or any other systemic agent prescribed for the purpose of treating meningioma.
  • An interval of ≥28 days from craniotomy and ≥7 days from stereotactic biopsy.
  • Availability of a paraffin-embedded archival tumor block sufficient to generate at least 25 unstained slides; or, if a paraffin tumor block is unavailable, at least 25 unstained slides.
  • Patients must be willing and able to undergo regular MRI scans of the brain.
  • Patients must have recovered to CTCAE grade ≤1 or pretreatment baseline from clinically significant adverse events related to prior therapy (exclusions include alopecia, laboratory values listed per inclusion criteria, lymphopenia, sensory neuropathy ≤ grade 2, or other ≤ grade 2 not constituting a safety risk based on the investigator's judgment).
  • Adequate organ and bone marrow function as defined below (within 21 days of treatment initiation):
  • Women of childbearing potential (WOCBP) and men able to father a child must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in the study, she must inform her treating physician immediately.
  • Able to understand and willing to sign an IRB approved written informed consent document.

Exclusion Criteria:

  • Participants with a clinical diagnosis of NF2 (either by NIH or Manchester criteria) or with a molecular diagnosis of NF2.
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm. This includes treatment with Somatostatin LAR within 4 weeks prior to treatment, or any patient receiving treatment with short-acting Octreotide that cannot be interrupted for greater than 24 hours before treatment.
  • Peptide receptor radionuclide therapy at any time prior to registration.
  • Known hypersensitivity to somatostatin analogues or any component of the 68Ga- DOTATATE or 177Lu-DOTATATE formulations.
  • Known additional malignancy that is progressing or requires active treatment within 2 years of start of study drug. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and in situ cervical cancer that has undergone potentially curative therapy.
  • Current or planned participation in another study of an investigational agent or investigational device.
  • Active infection requiring intravenous therapy with antibiotics.
  • Uncontrolled intercurrent illness including, but not limited to, clinically significant (i.e. active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), congestive heart failure (≥ NYHA class II), unstable angina pectoris, or serious cardiac arrhythmia requiring medication.
  • Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
  • Active Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test is positive).
  • Other severe acute or chronic medical or psychiatric conditions (within the past year) including recent or active suicidal ideation or behavior, or laboratory abnormalities that may increase the risk associated with study participation or treatment on study or may interfere with the interpretation of study results.
  • Pregnant and/or breastfeeding patients. Women of childbearing potential (WOCBP) must have a negative pregnancy test within 14 days of study entry.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03971461


Contacts
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Contact: Zacharia Sawaged 2122634431 Zacharia.Sawaged@nyulangone.org

Locations
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United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Zacharia Sawaged    212-263-4431    Zacharia.Sawaged@nyulangone.org   
Principal Investigator: Erik Sulman, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Erik Sukman, MD New York Langone Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03971461     History of Changes
Other Study ID Numbers: 18-00719
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Meningioma
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Octreotide
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents