This Phase 1 study is designed to assess the safety, tolerability, and schedule feasibility of administering Rhenium-186 NanoLiposome (REYOBIQ) at different dosing intervals following whole brain radiotherapy (WBRT) or proton craniospinal irradiation (PCSI).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Intraventricular injection via catheter. Patients will be assigned to three separate dosing schedules and once assigned they will remain on that dose level for up to 12 months (6 doses). Each dose will be 26.4 mCi, and participants will receive three doses for a total of 79.2 mCi. The time between doses will vary depending on the schedule (shown in table 1): * Schedule 1: Every 56 days * Schedule 2: Every 28 days * Schedule 3: Every 14 days
Incidence of Dose-Limiting Toxicities (DLTs)
The incidence of DLTs during the 28-day DLT window following any administration of REYOBIQ.
Time frame: Up to Month 13 (28 Days Post-Final Dose)
Central Nervous System Progression-Free Survival (CNS PFS)
Defined as the time from first treatment to the date of leptomeningeal metastases (LM) progression or death from any cause, whichever occurs first.
Time frame: Up to Year 5
Overall Survival (OS)
Defined as the time from first treatment to death from any cause.
Time frame: Up to Year 5
Overall Response Rate (ORR)
Defined as the proportion of evaluable patients achieving a best overall response (complete or partial response) prior to progression.
Time frame: Up to Year 5
Duration of Response (DoR)
Defined as the time from first treatment to the date of LM progression among responders.
Time frame: Up to Year 5
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