Neoplasms

Symptoms and General Pathology

All Conditions

Nervous System Diseases

Neoplasm Metastasis

Meningeal Carcinomatosis

Neoplastic Processes

Meningeal Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Each participant will receive a single 5cc administration of 186RNL.

At each dose level, a minimum of three to a maximum of six participants will be enrolled.

If no dose limiting toxicity is observed in the initial three participants, then the next higher dose level cohort will open for enrollment.

The dose escalation scheme will follow a modified Fibonacci dose escalation scheme.

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.

186RNL

Melissa Moore, PhD

Norman LaFrance, MD (CMO)

Lauren Nielsen

Nancy Gonzalez

Priya Kumthekar, MD

Karan Dixit

Matthew Tate

James Chandler

Roger Stupp

Rimas Lukas

Maciej Lesniak

Adam Sonabend

Kayn Schmidt

Margaret Schwartz

Jessica Bajas

Kellie Mora

Lilia Santana

Robin Buerki

Lauren Singer

Ditte Primdahl

Cassandra Faiella

Jake Lanning

Shirley Ong, MD

Omar Raslan

Michael Youssef, MD

Summer Stovall

Epp Goodwin

Andrew J Brenner, M.D., Ph.D.

William T Phillips, M.D.

John Floyd, M.D.

Eva Galvan, M.D.

Andrew Brenner, PhD

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.

Intraventricular Administration of Rhenium-186 NanoLiposome for Leptomeningeal Metastases

A Multicenter Phase 1 Clinical Study to Determine the Maximum Tolerated Dose/Maximum Feasible Dose, Safety,& Efficacy of Single Dose Rhenium-186 NanoLiposome (186RNL) Administered Via Intraventricular Catheter for Leptomeningeal Metastases

Safety will be evaluated by the incidence of AEs and SAEs graded according CTCAE version 5.0.

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.

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.

Determine the duration of response (DoR) defined as the time from first response to LM progression.

Determine progression free survival (PFS) defined as the time from first treatment to date of LM progression or death from any cause.

Determine the overall survival (OS) define as the time from first treatment to date of death.

Plus Therapeutics

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Intraventricular Administration of Rhenium-186 NanoLiposome for Leptomeningeal Metastases	NCT05034497	Leptomeningeal ...	186RNL	18 Years -	Plus Therapeutics
Intraventricular Administration of Rhenium-186 NanoLiposome for Leptomeningeal Metastases	NCT05034497	Leptomeningeal ...	186RNL	18 Years -	Plus Therapeutics

Spots Global Cancer Trial Database for 186rnl

Every month we try and update this database with for 186rnl cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for 186rnl

Every month we try and update this database with for 186rnl cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for 186rnl cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.