Phase I/II Study of Lutathera in Pediatric and Young Adult Patients with Recurrent and/or Progressive CNS Tumors which Express Somatostatin Type 2A Receptors and Demonstrate Uptake on DOTATATE PET
Phase: Recruiting
Condition(s): High-Grade Central Nervous System Tumors, Meningiomas, Medulloblastoma
NCT Number: NCT05278208 Other Study ID Number(s): CONNECT2007
What Is the Purpose of This Study?
In this research study, we want to find out if the study drug Lutathera, an IV infusion drug, is effective in treating different kinds of brain cancer. We also want to find the safest dose of this drug that does not cause serious side effects.
Who Can Take Part in This Study?
People who may be eligible for this study:
- Have been diagnosed with either a high-grade brain or spine tumor or a meningioma that expresses a specific protein called somatostatin receptor on its surface.
Phase I:
- Patient must be ≥ 4 and <12 years at the time of enrollment.
- Must have bi-dimensionally measurable disease, defined as at least one lesion that can be accurately measured in at least two dimensions
Phase II:
- Patient must be 12 to </=39 years at the time of enrollment.
For a full list of eligibility requirements, visit https://www.clinicaltrials.gov/study/NCT05278208
What Will Happen During This Study?
- Phase I involves administering Lutathera at a starting dose of 200 mCi adjusted for body surface area (BSA) every 8 weeks.
- The first 8 weeks will be used to observe any dose-limiting toxicities (DLTs) and establish the maximally tolerated dose (MTD) or recommended Phase II dose (RP2D).
- Once the MTD/RP2D is determined, an additional group of up to 10 patients will receive this dose to evaluate its preliminary efficacy.
- Phase II will continue with the recommended adult dose of 200 mCi every 8 weeks. The response to the treatment will be monitored using imaging techniques such as brain and/or spine MRI and DOTATATE PET scans after each cycle.
Principal Investigator
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Neuro-Oncology
Our highly experienced and internationally recognized team of pediatric neuro-oncologists, neurosurgeons and neuroradiologists will care for your child by providing the most advanced and innovative treatments, while at the same time, paying careful attention to all the needs and concerns of your child and family.
Central Nervous System (CNS) Tumor
The central nervous system is made up of the brain and the spinal cord. This system is responsible for sending, receiving and processing information throughout your body, controlling how your body functions. When tumors grow in the central nervous system, they can cause significant symptoms.
Brain Tumors
Brain tumors are the most common solid tumors in children. Primary brain tumors start in the brain and usually do not spread outside the brain tissue.