Intraventricular Administration of Rhenium-186 NanoLiposome for Leptomeningeal Metastases (ReSPECT-LM)
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|ClinicalTrials.gov Identifier: NCT05034497|
Recruitment Status : Recruiting
First Posted : September 5, 2021
Last Update Posted : July 13, 2022
|Condition or disease||Intervention/treatment||Phase|
|Leptomeningeal Metastasis||Drug: 186RNL||Phase 1|
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 of three 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 18.
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 (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||December 6, 2021|
|Estimated Primary Completion Date :||July 30, 2023|
|Estimated Study Completion Date :||December 30, 2023|
Experimental: Dose Escalation for Cohorts 1-3
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 as shown below:
COHORT ACTIVITY Cohort 1 (6.6 mCi) Cohort 2 (13.2 mCi) Cohort 3 (26.4 mCi)
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.
Other Name: Rhenium-186 NanoLiposome
- Incidence and severity of adverse events (AE) and serious adverse events (SAE) [ Time Frame: 12 months ]Safety will be evaluated by the incidence of AEs and SAEs graded according CTCAE version 5.0.
- Incidence of dose-limiting toxicities (DLT) [ Time Frame: 12 months ]Maximum Tolerated Dose (MTD) will be evaluated by testing increasing doses for cohorts 1 to 3 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.
- Determination of the overall response rate (ORR) [ Time Frame: 12 months ]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.
- Determination of the duration of response (DoR) [ Time Frame: 12 months ]Determine the duration of response (DoR) defined as the time from first response to LM progression.
- Determination of progression free survival (PFS) [ Time Frame: 12 months ]Determine progression free survival (PFS) defined as the time from first treatment to date of LM progression or death from any cause.
- Overall survival (OS) [ Time Frame: 12 Months ]Determine the overall survival (OS) define as the time from first treatment to date of death.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05034497
|Contact: Erika Butler, MSemail@example.com|
|Contact: Norman LaFrance, MD (CMO)||firstname.lastname@example.org|
|United States, Texas|
|Universiy of Texas Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Omar Raslan 214-648-6691 email@example.com|
|Principal Investigator: Michael Youssef, MD|
|UT Health Science Center San Antonio / Mays Cancer Center||Recruiting|
|San Antonio, Texas, United States, 78229|
|Contact: Epp Goodwin 210-450-5798|
|Principal Investigator: Andrew J Brenner, M.D., Ph.D.|
|Sub-Investigator: William T Phillips, M.D.|
|Sub-Investigator: John Floyd, M.D.|
|Sub-Investigator: Eva Galvan, M.D.|
|Study Chair:||Marc Hedrick, MD||Plus Therapeutics, President and CEO|