Phase II Study of 177Lu-DOTATATE Radionuclide in Adults With Progressive or High-risk Meningioma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03971461|
Recruitment Status : Recruiting
First Posted : June 3, 2019
Last Update Posted : July 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Meningioma||Drug: Lutathera||Phase 2|
|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)|
|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|
administered intravenously every 8 weeks for a total of 4 doses
Other Name: 177Lu-DOTATATE
- 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
- 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.
- 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.
- 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.
- 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.
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
|Contact: Zacharia Sawaged||2122634431||Zacharia.Sawaged@nyulangone.org|
|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|
|Principal Investigator:||Erik Sukman, MD||New York Langone Health|