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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Multiple Doses of 186RNL
The Cancer Therapy and Research Center at UTHSCSA
San Antonio, Texas, United States
RECRUITINGMaximum 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
Determine the objective response rate (ORR).
Determine the overall response rate (ORR) defined as the proportion of all evaluable participants achieving a response as the best overall response at the time of progression.
Time frame: 13 months
Determine the overall survival (OS).
The time from first treatment to date of death.
Time frame: 13 months
Characterize the dosimetry profile of 186RNL.
using the following equation to calculate the average radiation-absorbed dose in the CSF Volume (Eckerman and Endo 2008): D (Gy) = 7.126 (Gy.g/mCi.h) × A cummu. (mCi.h)/ m (g) D is the average radiation-absorbed dose in Gy. A cummu. is the cumulative radioactivity in mCi.h calculated as described above. m is the weight of the radioactivity distribution volume in grams. Given that there is no specific tumor mass to use for organ mass in grams identifiable post-infusion, the Sponsor proposes to use the estimated total CSF volume to calculate the absorbed dose to the CSF. To perform radiation-absorbed dose calculation, the weight will be calculated from the average CSF volume (Adult Male: 140 ml; Adult Female: 120 ml), assuming the density of 1 g/cm3.
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Time frame: 13 months
Determine neurologic progression-free survival (PFS).
The time from first treatment to progression.
Time frame: 13 months
Evaluate Neurologic status by NANO scale
Neurologic Assessment in Neuro- Oncology (NANO) The NANO scale is a quantifiable evaluation of 9 relevant neurologic domains based on direct observation and testing conducted during routine office visits. The score defines overall response criteria. The scale scores nine domains: gait, strength, ataxia, sensibility, visual fields, facial paralysis, language, level of consciousness, and behavior. Each domain has a score between 0 and 2 or 3, with 0 indicating normal function and higher scores indicating increasing deficits.
Time frame: 13 months