Study on the Safety and Dosimetry of Lutathera in Adolescents with GEP-NETs and PPGLs
Sponsor: Advanced Accelerator Applications
ClinicalTrials ID:NCT04711135
This clinical trial is testing the safety and dosage of Lutathera, a treatment for adolescents aged 12 to under 18 with specific types of tumors called GEP-NETs and PPGLs. The study aims to enroll at least 8 patients with GEP-NETs and as many as possible with PPGLs.
Patient Parameters
| Parameter | Options |
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Program Overview
This study is designed to evaluate how safe Lutathera is and how it is processed in the body for adolescents with certain tumors that have somatostatin receptors. The study will include patients aged 12 to under 18 with GEP-NETs or PPGLs. Participants will receive Lutathera treatment every 8 weeks for a total of 4 doses, and their health will be monitored for 10 years after the last dose to check for any long-term effects.
Description
Participants in this study will go through a screening period of up to 2 weeks, followed by a treatment period where they will receive Lutathera every 8 weeks for a total of 4 doses. Each dose will be given with an amino acid solution to protect the kidneys and medication to prevent nausea. The study will also involve tests to measure how the body absorbs and processes the treatment after the first dose. If these tests can't be done right away, they will be completed as soon as possible. The study includes a follow-up period of 10 years to monitor for any long-term effects, with a focus on safety and how the treatment affects the body. An independent board will review safety data to ensure the well-being of participants.
Eligibility Criteria
Inclusion Criteria
- Adolescents aged 12 to under 18 with specific types of tumors called GEP-NETs or PPGLs that cannot be surgically removed.
- Tumors must have somatostatin receptors, confirmed by imaging tests.
- Must have a performance status score of 50 or higher, indicating they can perform daily activities.
- Parents must understand and agree to the study, and adolescents must also agree to participate.
Exclusion Criteria
- Poor kidney function or low blood cell counts.
- High bilirubin levels or low albumin levels in the blood.
- Pregnant or breastfeeding females, or females not using effective birth control.
- Males not agreeing to use birth control.
- Other treatment options deemed more suitable by the doctor.
- Current urinary incontinence.
- Other untreated cancers, except for certain skin or cervical cancers.
- Allergies to the study drug or its ingredients.
- Other significant uncontrolled medical conditions.
- Inability to undergo CT scans due to allergies or kidney issues, unless MRI is possible.
- Recent participation in another clinical trial within the last 30 days.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Kentucky | 40536 | Lexington | Kentucky |
| Cincinnati Children's Hospital | 45229-3039 | Cincinnati | Ohio |
| Children's Hospital of Philadelphia | 19104 | Philadelphia | Pennsylvania |
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