This is an open-label Phase I clinical study that will administer a single dose of 186RNL via intraventricular catheter for treatment of Leptomeningeal Metastases (LM).
This Phase I clinical study evaluates a single dose of 186RNL (radionuclide clinical study drug) administered through an intraventricular catheter (Ommaya reservoir) in participants with Leptomeningeal Metastases (LM). The clinical study treatment consists of a single administered 5cc dose of 186RNL per participant. The clinical study will include the evaluation at separate dose levels. Three to six participants may be treated at each dose. The maximum number of participants to be enrolled in the study is 27. The clinical study treatment will be administered, following a CSF flow study, on an outpatient basis by the clinical study physician. Participants will be followed for up to 12 months after the clinical study drug is administered. The U.S. Food and Drug Administration (FDA) has not approved 186RNL for this specific disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
All participants will be required to have an Ommaya Reservoir and a CSF Flow Study. Participants will receive a single 5cc dose of 186RNL via Ommaya Reservoir.
Northwestern Memorial Hospital Olson Pavilion
Chicago, Illinois, United States
Northshore University Hospital
Manhasset, New York, United States
Lenox Hill Hospital
New York, New York, United States
Ohio State University Hospital
Columbus, Ohio, United States
Incidence and severity of adverse events (AE) and serious adverse events (SAE)
Safety will be evaluated by the incidence of AEs and SAEs graded according CTCAE version 5.0.
Time frame: 12 months
Incidence of dose-limiting toxicities (DLT)
Maximum Tolerated Dose (MTD) will be evaluated by testing increasing doses with 3 to 6 participants in each cohort. MTD reflects the highest dose of drug that did not cause a Dose-Limiting Toxicity (DLT) in \> 33% of participants.
Time frame: 12 months
Determination of the overall 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: 12 months
Determination of the duration of response (DoR)
Determine the duration of response (DoR) defined as the time from first response to LM progression.
Time frame: 12 months
Determination of progression free survival (PFS)
Determine progression free survival (PFS) defined as the time from first treatment to date of LM progression or death from any cause.
Time frame: 12 months
Overall survival (OS)
Determine the overall survival (OS) define as the time from first treatment to date of death.
Time frame: 12 Months
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Universiy of Texas Southwestern Medical Center
Dallas, Texas, United States
UT Health Science Center San Antonio / Mays Cancer Center
San Antonio, Texas, United States