Condition or disease | Intervention/treatment | Phase |
---|---|---|
Meningioma | Drug: Lutathera | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 32 participants |
Allocation: | N/A |
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 2022 |
Estimated Study Completion Date : | May 2023 |
Arm | Intervention/treatment |
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Experimental: Lutathera |
Drug: Lutathera
administered intravenously every 8 weeks for a total of 4 doses
Other Name: 177Lu-DOTATATE
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histologically confirmed diagnosis WHO grade I-III meningioma:
a. For grade I meningioma, subjects must have: i. 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 12 months.
or ii. Progressive residual tumor after maximal safe resection, be located at or near critical organs at-risk and considered to be high-risk for radiation injury by the treating investigator. Prior external beam radiotherapy is not required for these subjects.
b. For Grade II or III meningioma, subjects must have either: i. Progressive disease after at least 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 12 months or ii. Residual measurable disease after surgery without requirement of progression.
Positive 68Ga-DOTATATE uptake on PET-MRI.
Availability of a paraffin-embedded archival tumor block from most recent tumor resection sufficient to generate at minimum 8 unstained slides but preferably up to 25 unstained slides; or, if a paraffin tumor block is unavailable, at minimum 8 unstained slides but preferably up to 25 unstained slides.
a. Positive SSTR2 expression in the most recent tumor specimen must be confirmed by central pathology review.
Adequate organ and bone marrow function as defined below (within 21 days of treatment initiation):
Exclusion Criteria
Contact: Michelle Del Rosario, MSN, RN, CNL | 646-501-4718 | michelle.delrosario@nyulangone.org | |
Contact: Angelica Husni | Angelica.Husni@nyulangone.org |
United States, New York | |
NYU Langone Health | Recruiting |
New York, New York, United States, 10016 | |
Contact: Vivian Chan 212-263-4436 Vivian.Chan@nyulangone.org | |
Principal Investigator: Erik Sulman, MD | |
Sub-Investigator: Sylvia Kurz, MD |
Principal Investigator: | Erik Sukman, MD | New York Langone Health | |
Principal Investigator: | Sylvia Kurz, MD | NYU Langone Health |
Tracking Information | |||||||||
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First Submitted Date ICMJE | May 30, 2019 | ||||||||
First Posted Date ICMJE | June 3, 2019 | ||||||||
Last Update Posted Date | June 8, 2021 | ||||||||
Actual Study Start Date ICMJE | May 15, 2019 | ||||||||
Estimated Primary Completion Date | May 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Phase II Study of 177Lu-DOTATATE Radionuclide in Adults With Progressive or High-risk Meningioma | ||||||||
Official Title ICMJE | A Single Arm, Open-label, Multicenter Phase II Study of 177Lu-DOTATATE Radionuclide in Adults With Progressive or High-risk Meningioma | ||||||||
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. | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: N/A 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 |
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Condition ICMJE | Meningioma | ||||||||
Intervention ICMJE | Drug: Lutathera
administered intravenously every 8 weeks for a total of 4 doses
Other Name: 177Lu-DOTATATE
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Study Arms ICMJE | Experimental: Lutathera
Intervention: Drug: Lutathera
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
32 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | May 2023 | ||||||||
Estimated Primary Completion Date | May 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03971461 | ||||||||
Other Study ID Numbers ICMJE | 18-00719 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Responsible Party | NYU Langone Health | ||||||||
Study Sponsor ICMJE | NYU Langone Health | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | NYU Langone Health | ||||||||
Verification Date | June 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |