Actively Recruiting
Multiple Dose Intraventricular Administration of Rhenium-186 NanoLiposome for Leptomeningeal Metastases
Led by Plus Therapeutics · Updated on 2025-08-01
24
Participants Needed
1
Research Sites
326 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, multicenter, Phase 1 study to determine the safety and efficacy of multiple doses at defined intervals of rhenium (186Re) obisbemeda (rhenium-186 nanoliposome, 186RNL) administered via intraventricular catheter for any primary solid tumor cancer with leptomeningeal metastases to identify an MTD/MFD for a given dose, interval duration, and number of doses.
CONDITIONS
Official Title
Multiple Dose Intraventricular Administration of Rhenium-186 NanoLiposome for Leptomeningeal Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age
- Able to understand the study and provide written informed consent
- Documented leptomeningeal metastases from any primary solid tumor cancer per clinical guidelines
- Karnofsky performance status between 70 and 100
- Acceptable liver function: bilirubin ≤ 1.5 times upper limit of normal; AST and ALT ≤ 3 times upper limit for normal liver or ≤ 5 times for liver metastasis
- Acceptable kidney function: creatinine clearance ≥ 60 mL/min (Cockcroft-Gault Equation)
- Acceptable blood counts without support: ANC ≥ 1000 cells/μL; platelet count ≥ 75,000/μL; hemoglobin ≥ 9.0 g/dL
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective contraception during and for 6 months after last dose
- Normal cerebrospinal fluid flow confirmed by accepted CSF flow study
- Corticosteroids allowed as needed
You will not qualify if you...
- Not recovered to Grade ≤1 from adverse events due to prior cancer treatments, except alopecia, anemia, neutropenia, and lymphopenia
- Contraindications to intraventricular catheter placement
- Presence or need for ventriculo-peritoneal or ventriculo-atrial shunt
- Pregnant, breastfeeding, or possibly pregnant females without negative pregnancy test
- Serious illnesses interfering with treatment schedule
- Prior whole brain radiation therapy (with some exceptions for spinal cord or stereotactic radiosurgery within defined dose and timing limits)
- Concurrent or recent intrathecal therapy within 14 days
- Concurrent systemic therapy unless leptomeningeal metastases developed during therapy and without more than grade 1 myelosuppression
- Systemic therapy within 28 days prior to study
- Expected survival less than 60 days
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Cancer Therapy and Research Center at UTHSCSA
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
R
Rachael Hershey
CONTACT
A
Andrew Brenner, M.D.,Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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