Multiple Dose Intraventricular Administration of Rhenium-186 NanoLiposome for Leptomeningeal Meta… (NCT07098806) | Clinical Trial Compass
RecruitingPhase 1
Multiple Dose Intraventricular Administration of Rhenium-186 NanoLiposome for Leptomeningeal Metastases
United States24 participantsStarted 2025-07-02
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. At least 18 years of age.
✓. Ability to understand the purposes and risks of the study and has signed a written informed consent document approved by the site-specific IRB.
✓. Documented LM from any primary solid tumor cancer per EANO-ESMO Clinical Practice Guidelines (Types I or IIA-C).
✓. Karnofsky performance status of 70 to 100.
✓. Acceptable liver function:
✓. Bilirubin ≤ 1.5 times the upper limit of normal.
✓. AST (SGOT) and ALT (SGPT) ≤ 3.0 times the upper limit of normal for subjects with normal liver.
✓. AST (SGOT) and ALT (SGPT) ≤ 5.0 times the upper limit of normal for subjects with liver metastasis.
Exclusion criteria
✕. The subject has not recovered to the current National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v5.0) Grade ≤1 from adverse events (AEs) due to antineoplastic agents, investigational drugs, or other medications that were administered prior to study, at time of study registration.
✕. Contraindications to the placement of an intraventricular catheter (i.e., Ommaya reservoir.)
✕. Presence of or need for a Ventriculo-peritoneal or ventriculo-atrial shunt.
✕. Females of childbearing potential who are pregnant, breastfeeding, or may possibly be pregnant, without a negative serum pregnancy test (see inclusion criteria).
What they're measuring
1
Maximum Tolerated Dose
Timeframe: 13 months
2
Dose Distribution of 186RNL
Timeframe: 13 months
3
Safety and tolerability of multiple dose treatment
✕. Serious intercurrent illnesses, which could interfere with the planned treatment schedule.
✕. 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.