OncoMatch/Clinical Trials/NCT07098806
Multiple Dose Intraventricular Administration of Rhenium-186 NanoLiposome for Leptomeningeal Metastases
Is NCT07098806 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies 186RNL for leptomeningeal metastasis.
Treatment: 186RNL — 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.
Check if I qualifyExtracted eligibility criteria
Disease stage
Metastatic disease required
Performance status
KARNOFSKY 70–100
Prior therapy
Cannot have received: intrathecal therapy
Exception: Prior intrathecal therapy allowed if given ≥14 days before study registration
Intrathecal therapy given less than 14 days before study registration
Cannot have received: intrathecal therapy
Concurrent intrathecal therapy
Cannot have received: systemically delivered therapy
Exception: Allowed if LM develops while on systemic therapy AND systemic therapy is NOT associated with more than grade 1 myelosuppression
Systemically delivered therapy UNLESS LM develops while on systemically delivered therapy AND the systemically delivered therapy is NOT associated with more than grade 1 myelosuppression
Cannot have received: systemically delivered therapy
Exception: Prior systemic therapy allowed if given ≥28 days before study registration
Systemically delivered therapy given less than 28 days before study registration
Cannot have received: whole brain radiation therapy
Exception: Prior spinal cord/cauda equina or partial brain/SRS allowed under specified dose/timing conditions
Patients who had any therapeutic radiation dose to the whole brain regardless of when the radiation treatment was delivered, except: Prior radiation dose to the spinal cord and/or cauda equina is allowed if the equivalent dose in 2 Gy fractions (EQD2) was ≤ 30 Gy to the spinal cord and/or cauda equina using α/β ratio of 3 and if prior radiotherapy has been > 14 days and ≤ 6 months, or was ≤45 Gy to the spinal cord and/or cauda equina using α/β ratio of 3 and if prior radiotherapy has been > 6 months. Prior stereotactic radiosurgery (SRS) to the brain or partial brain radiotherapy is allowed if the equivalent dose in 2 Gy fractions (EQD2) was ≤ 30 Gy to brainstem and/or optic structures (optic nerves, optic chiasm) using α/β ratio of 3 and if prior radiotherapy has been > 14 days and ≤ 6 months, or was ≤ 45 Gy to the brainstem and/or optic structures (optic nerves, optic chiasm) using α/β ratio of 3 and if prior radiotherapy has been > 6 months.
Lab requirements
Blood counts
ANC ≥ 1000/μL; Platelet count ≥ 75,000/μL; Hemoglobin ≥ 9.0 g/dL (without hematologic support)
Kidney function
Creatinine clearance ≥ 60 mL/min (Cockcroft-Gault Equation)
Liver function
Bilirubin ≤ 1.5x ULN; AST/ALT ≤ 3.0x ULN for subjects with normal liver; AST/ALT ≤ 5.0x ULN for subjects with liver metastasis
Acceptable liver function: Bilirubin ≤ 1.5x ULN; AST/ALT ≤ 3.0x ULN for subjects with normal liver; AST/ALT ≤ 5.0x ULN for subjects with liver metastasis. Acceptable renal function: Creatinine clearance ≥ 60 mL/min (Cockcroft-Gault Equation). Acceptable hematologic functioning (without hematologic support): ANC ≥ 1000/μL; Platelet count ≥ 75,000/μL; Hemoglobin ≥ 9.0 g/dL.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The Cancer Therapy and Research Center at UTHSCSA · San Antonio, Texas
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