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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

Must not have

Significant coagulation abnormalities such as inherited bleeding diathesis or acquired coagulopathy with unacceptable risks of bleeding

Patients who had any dose to the spinal cord or whole brain radiation therapy, regardless of when the radiation treatment was delivered. Prior, non-CNS radiation for primary tumor is allowed

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a bleeding disorder that poses a high risk of bleeding.

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I have received radiation to my brain or spinal cord, or had radiation for a tumor not in my brain.

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I have a condition where fluid builds up in my brain, causing symptoms.

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I still have significant side effects from previous cancer treatments.

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I do not have any serious illnesses like heart problems, uncontrolled infections, or recent strokes.

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I haven't taken any chemotherapy that affects the brain within the last 14 days or 5 half-lives, whichever is shorter.

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I haven't had certain cancer drugs within the specified times before starting 186RNL treatment.

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My CSF flow study shows impairment as confirmed by recent imaging.

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I am not pregnant, breastfeeding, or potentially pregnant without a confirmed negative pregnancy test.

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I do not have severe organ problems like kidney, heart, liver, lung, or stomach issues.

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I have a non-programmable shunt and can have an Ommaya reservoir placed.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Incidence of dose-limiting toxicities (DLT)

Secondary study objectives

Determination of progression free survival (PFS)

Determination of the duration of response (DoR)

Determination of the overall response rate (ORR)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 17Eligibility criteria met