A 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
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.
Arms & interventions
- Drug186RNL
Multiple Doses of 186RNL
Outcome measures
Primary
Maximum Tolerated Dose
Evaluation of any toxicity associated with research treatment per Common Criteria for Adverse Events.
Time frame: 13 months
Dose Distribution of 186RNL
SPECT imaging of the radioactive materials spread in the Cerebrospinal Fluid.
Time frame: 13 months
Safety and tolerability of multiple dose treatment
Evaluation of any toxicity associated with research treatment as determined by National Cancer Institute (NCI) common Terminology Criteria for adverse events (CTCAE).
Time frame: 13 months
Secondary
Determine the objective response rate (ORR).
Time frame: 13 months
Determine the overall survival (OS).
Time frame: 13 months
Characterize the dosimetry profile of 186RNL.
Time frame: 13 months
Determine neurologic progression-free survival (PFS).
Time frame: 13 months
Evaluate Neurologic status by NANO scale
Time frame: 13 months
Eligibility criteria
Study locations (1)
The Cancer Therapy and Research Center at UTHSCSA
San Antonio, Texas, 78229