Rhenium-186 NanoLiposomes for Brain Tumor

Overseen By Rachael Hershey

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Plus Therapeutics

Must be taking: Antiepileptics, Corticosteroids

Must not be taking: Investigational agents, Biologic agents

Disqualifiers: Uncontrolled hypertension, Cardiac arrhythmias, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals with recurring brain tumors, specifically gliomas, who have previously undergone treatment with Rhenium-186 NanoLiposomes. The trial aims to determine if a single dose of this treatment is safe and well-tolerated when administered directly into the brain. Individuals whose brain tumors have returned after standard treatments like surgery or chemotherapy might be suitable candidates, especially if they have tried Rhenium-186 before and at least 90 days have passed since their last dose. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop all current medications, but it does require a stable dose of antiepileptic medications for two weeks and a stable or decreasing dose of corticosteroids for two weeks before starting. Some prior cancer treatments must be stopped for a certain period before the trial.

Is there any evidence suggesting that Rhenium-186 NanoLiposomes are likely to be safe for humans?

Research has shown that Rhenium-186 NanoLiposomes are usually safe for patients. Studies have found that this treatment, used for patients with recurring brain tumors, delivers a strong dose of radiation directly to the tumor without causing major side effects. In earlier studies, patients received this treatment without serious harmful reactions. This method targets tumors more effectively than traditional radiation therapy. Additionally, one study found no negative effects on the brain with doses up to 6 mCi, suggesting that even higher doses might be safe, though more research is needed to confirm this. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for brain tumors, which often include surgery, radiation, and chemotherapy, Rhenium-186 NanoLiposomes offer a unique approach by delivering a radioactive particle directly to the tumor. This treatment uses a novel delivery method where nanoparticles transport the radioactive Rhenium-186 straight to the cancer cells, potentially increasing precision and reducing damage to healthy surrounding tissues. Researchers are excited about this treatment because it targets the tumor more directly, which may enhance effectiveness and minimize side effects compared to traditional methods.

What evidence suggests that Rhenium-186 NanoLiposomes might be an effective treatment for brain tumors?

Research has shown that Rhenium-186 NanoLiposomes (186RNL) may help treat brain tumors. One study found that patients receiving a high dose of 186RNL lived an average of 487 days. This result is promising, particularly for those with recurrent gliomas. The treatment targets brain tumors with high radiation while causing few side effects. Overall, these findings suggest that 186RNL could extend the lives of brain cancer patients. ^{4 5 6 7 8}

Who Is on the Research Team?

Andrew J Brenner, PhD

Principal Investigator

The Cancer Therapy and Research Center at UTHSCSA

Are You a Good Fit for This Trial?

This trial is for adults over 18 with certain high-grade brain tumors (Grade III or IV gliomas) who've already been treated with Rhenium-186 NanoLiposomes. They should be stable on medications for seizures and cerebral edema, have acceptable liver function, an ECOG performance status of 0 to 3, and a life expectancy of at least two months.

Inclusion Criteria

Life expectancy of at least 2 months

I can care for myself but may not be able to do all my normal activities.

I've been on a stable dose of my seizure medication for at least two weeks without seizures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of 186RNL administered via convection enhanced delivery catheter

1 day

1 visit (in-person)

Post-treatment Evaluation

Evaluations are conducted at Days 3, 7, 14, 28, and every 28 days thereafter until disease progression and resolution of toxicities

12 weeks minimum

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Rhenium-186 NanoLiposomes

Trial Overview The study tests the safety and effectiveness of giving a second dose of Rhenium-186 NanoLiposomes via an intraventricular catheter to patients whose brain tumors returned after initial treatment. It's open-label and multicenter, meaning both researchers and participants know what treatment is being given.

How Is the Trial Designed?

Group I: Retreatment with Rhenium Liposome Experimental Treatment 1 Intervention

Each participant will receive a single administration of 186RNL. The proposed dose is up to 8.8 mL as a single administration with an administered dose of 22.3 mCi.

Who Is Running the Clinical Trial?

Plus Therapeutics

Lead Sponsor

Trials

3

Recruited

110+

Published Research Related to This Trial

Liposomes containing a radioactive rhenium complex were successfully created, with about 45% of the complex incorporated into the liposome bilayer, indicating effective encapsulation for potential therapeutic use.

The stability of these liposomes improved with the addition of ascorbic acid, reducing radioactivity loss from 40% to 20% over 8 days, which is crucial for their application in beta-radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A lipophilic complex with 186Re/188Re incorporated in liposomes suitable for radiotherapy. Häfeli, U., Tiefenauer, LX., Schbiger, PA., et al.[2019]

Brachytherapy using rhenium-186 (186Re) liposomes delivered via convection-enhanced delivery showed promising results in a rat model of glioma, with doses up to 1850 Gy administered without significant toxicity.

Treatment with (186)Re-liposomes significantly improved median survival (126 days) compared to controls (49 days), indicating a strong potential for this method in treating primary brain tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rhenium-186 liposomes as convection-enhanced nanoparticle brachytherapy for treatment of glioblastoma. Phillips, WT., Goins, B., Bao, A., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05460507

NCT05460507 | Safety & Efficacy/Tolerability of Rhenium ... This is an open-label, multicenter, Phase 1 study to establish the safety and efficacy/tolerability of a single dose of 186RNL by the intraventricular route.

2. ncoda.org ncoda.org/news/a-new-way-to-treat-brain-cancer/

OncolyticsToday: A New Way to Treat Brain Cancer? The study demonstrated that 186RNL can deliver high radiation doses to brain tumors with minimal toxicity, showing potential survival benefits.

3. jnm.snmjournals.org jnm.snmjournals.org/content/63/supplement_2/2488

Rhenium-186-NanoLiposome (186RNL) in the treatment ... Initial treatment results are very encouraging with a 13-patient subset receiving a radiation dose >100 Gy with an average 487 day survival with ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3309864/

Rhenium-186 liposomes as convection-enhanced ... Rhenium-186 liposomes as convection-enhanced nanoparticle brachytherapy for treatment of glioblastoma. William T Phillips.

5. nature.com nature.com/articles/s41467-025-57263-1

Convection enhanced delivery of Rhenium ( 186 Re) ... Based on these data, the no adverse effect limit as related to brain pathology was determined to be 6 mCi 186RNL as a single infusion when ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05460507

NCT05460507 | Safety & Efficacy/Tolerability of Rhenium ... This is an open-label, multicenter, Phase 1 study to establish the safety and efficacy/tolerability of a single dose of 186RNL by the intraventricular route ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2021.39.15_suppl.2061

Safety and feasibility of rhenium-186 nanoliposome ... 186 RNL administered by CED to patients with recurrent glioma results in a much higher absorbed dose of radiation to the tumor compared to EBRT without ...

8. jnm.snmjournals.org jnm.snmjournals.org/content/64/supplement_1/P988

Safety and Feasibility Results from a Phase 1/2 Clinical Trial ... A single dose of by CED in adult patients with recurrent glioma achieves high absorbed doses without significant toxicity, is well tolerated, with favorable ...