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Radioisotope

Rhenium-186 NanoLiposome for Leptomeningeal Metastasis (ReSPECT-LM Trial)

Phase 1

Recruiting

Led By Andrew Brenner, PhD

Research Sponsored by Plus Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Acceptable liver function: Bilirubin 1.5 times upper limit of normal, AST (SGOT) and ALT (SGPT) ≤ 3.0 times upper limit of normal for subjects with normal liver, AST (SGOT) and ALT (SGPT) ≤ 5.0 times upper limit of normal for subjects with liver metastasis

Subject has proven and documented LM that meets the requirements for the study: Current EANO-ESMO Clinical Practice Guidelines Type 1 and 2 LM of any primary type. 2D is excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

ReSPECT-LM Trial Summary

This trial will test a new treatment for cancer that has spread to the fluid-filled space around the brain.

Who is the study for?

Adults with documented Leptomeningeal Metastases (LM) who understand the study and consent to participate. They must have a Karnofsky performance status of 60-100, proper kidney and liver function, acceptable blood counts, not be pregnant or breastfeeding, use effective contraception, and have no severe illnesses or recent significant cardiovascular events.Check my eligibility

What is being tested?

The trial is testing a single dose of an experimental treatment called 186RNL administered directly into the cerebrospinal fluid via a catheter for patients with LM. It's an early-phase study to see how safe it is and how well it works.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include typical reactions related to intraventricular drug administration such as headache, infection at the catheter site, bleeding or clotting issues due to abnormal CSF flow or coagulation abnormalities.

ReSPECT-LM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver function tests are within the required range.

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My leptomeningeal metastases (LM) fit the study's specific type requirements.

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I am 18 years old or older.

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My kidney function is within the normal range.

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My kidneys are functioning well, with a creatinine clearance rate of 60 mL/min or higher.

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I can care for myself but may not be able to do active work.

ReSPECT-LM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence and severity of adverse events (AE) and serious adverse events (SAE)

Incidence of dose-limiting toxicities (DLT)

Secondary outcome measures

Determination of progression free survival (PFS)

Determination of the duration of response (DoR)

Determination of the overall response rate (ORR)

+1 more

ReSPECT-LM Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose EscalationExperimental Treatment1 Intervention

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.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Plus TherapeuticsLead Sponsor

2 Previous Clinical Trials

95 Total Patients Enrolled

Andrew Brenner, PhDPrincipal InvestigatorThe Cancer Therapy and Research Center at UTHSCSA

Marc Hedrick, MDStudy ChairPlus Therapeutics, President and CEO

2 Previous Clinical Trials

95 Total Patients Enrolled

Media Library

Leptomeningeal Metastasis Clinical Trial 2023: 186RNL Highlights & Side Effects. Trial Name: NCT05034497 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cap of participants in this research trial?

"Indeed, the data accessible on clinicaltrials.gov conveys that this study is currently enrolling participants. The trial was first posted in December 2021 and its most recent update occurred in July 2022; it seeks 18 individuals to participate between two sites."

Answered by AI

To what extent could exposure to 186RNL be detrimental for human health?

"Due to the limited data surrounding 186RNL, it is given a score of 1 in terms of safety. This reflects that this compound is currently in Phase I clinical trials."

Answered by AI

What is the primary aim of this research project?

"This medical trial will span 12 months, during which the primary outcome of interest is tracking Adverse and Serious Adverse Events. Secondary outcomes include Progression Free Survival, Overall Survival, and determining an overall response rate."

Answered by AI

Is there any further opportunity to join this clinical research?

"Affirmative. According to information on clinicaltrials.gov, this medical trial which opened for recruitment on December 6th 2021 is currently recruiting patients. 18 individuals need to be enrolled at 2 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intraventricular Administration of Rhenium-186 NanoLiposome for Leptomeningeal Metastases

2021. "Intraventricular Administration of Rhenium-186 NanoLiposome for Leptomeningeal Metastases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05034497.