Rhenium Liposome Treatment for Brain Cancer

Recruiting at 3 trial locations

Overseen By Rachael Hershey

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Plus Therapeutics

Must be taking: Antiepileptics, Corticosteroids

Must not be taking: Bevacizumab, Investigational agents

Disqualifiers: Hypertension, Cardiac arrhythmias, others

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

Compensation: Varies

Number of Visits: Unknown

55 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called Rhenium Liposome for individuals with brain cancer that has returned or continued to grow despite previous treatments such as surgery, radiation, or chemotherapy. The trial aims to assess the safety, tolerability, and distribution of this treatment within the brain. Participants will receive varying doses to determine the most effective amount that avoids serious side effects. This trial may suit those with a specific type of brain cancer known as recurrent malignant glioma who have experienced progression after standard treatments. 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 need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on antiepileptic medications or corticosteroids, you must have a stable dose for at least two weeks before starting the study.

Is there any evidence suggesting that Rhenium Liposome Treatment is likely to be safe for humans?

Research has shown that the Rhenium Liposome Treatment (186RNL) has been safe in past studies. In one study, adult patients with recurring brain tumors received a single dose of 186RNL, which was absorbed well without causing major harm. This indicates the treatment did not lead to serious side effects. Another study found no unwanted side effects related to the treatment after patients received 186RNL. Additionally, a single dose of up to 6 mCi of 186RNL did not harm brain health. These findings suggest the treatment is generally safe within this amount. Overall, 186RNL has been well-tolerated and has not caused significant health issues in previous trials. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Rhenium Liposome Treatment is unique because it uses a novel delivery method with liposomes to precisely target brain cancer cells. Unlike traditional treatments like chemotherapy or radiation, which can affect healthy cells and cause significant side effects, this treatment focuses on delivering radioactive rhenium directly to the tumor site. Researchers are excited about its potential to minimize damage to healthy brain tissue while effectively targeting cancer cells, offering a promising new direction in brain cancer treatment.

What evidence suggests that Rhenium Liposome Treatment might be an effective treatment for brain cancer?

Research has shown that Rhenium-186 liposome treatment may hold promise for brain cancer. Studies on similar cancers, such as head and neck cancer, have demonstrated positive effects from this treatment. In this trial, participants will receive varying doses of Rhenium-186 liposome treatment to determine the optimal dose. In previous studies, brain cancer patients who received a high dose of radiation from this treatment had an average survival time of about 487 days. This is significant because the usual survival time for similar conditions is around 8.5 months. These findings suggest that Rhenium-186 liposome treatment could offer hope for longer survival in challenging brain cancer cases. ^{1 2 6 7}

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?

Adults with Grade III/IV recurrent glioma who've had standard treatments can join this trial. They must understand the study, not have seizures or recent serious health issues, and agree to use contraception. Excluded are those with MRI contraindications, unresolved side effects from previous treatments, acute bleeding in the brain, other active cancers (except certain skin cancers), or those who've recently received specific cancer therapies.

Inclusion Criteria

All women of childbearing potential must have a negative serum pregnancy test and male and female subjects must agree to use effective means of contraception with their partner from entry into the study through 6 months after the last dose

Life expectancy of at least 2 months

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

Exclusion Criteria

My tumor is 20 cm3 or smaller.

Evidence of acute intracranial or intratumoral hemorrhage

Unable or contraindicated to undergo MRI scan

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Treatment

Participants receive a single dose of 186RNL through convection enhanced delivery, with dose escalation to determine the maximum tolerated dose

8 weeks

Multiple visits for dose escalation and monitoring

Phase II Treatment

Participants receive a non-DLT dose of 186RNL determined from Phase I, administered through convection enhanced delivery

12 months

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety, efficacy, and progression-free survival after treatment

36 months

Periodic visits for follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• Rhenium Liposome Treatment

Trial Overview

The ReSPECT trial is testing Rhenium Liposome Treatment's safety and effectiveness for brain tumors. It involves increasing doses of a radioactive substance delivered directly into the tumor to find the highest dose patients can tolerate without severe side effects before assessing its efficacy.

How Is the Trial Designed?

Group I: 186Rhenium Liposome Treatment Experimental Treatment 1 Intervention

Arm Phase I: Experimental: Dose Escalation for Cohorts 1-8 Each participant will receive a single 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 (1.0 mCi) Cohort 2 (2.0 mCi) Cohort 3 (4.0 mCi) Cohort 4 (8.0 mCi) Cohort 5 (13.4 mCi) Cohort 6 (22.3 mCi) Cohort 7 (31.2 mCi) Cohort 8 (41.5 mCi) Phase 2: Single arm, prospective study utilizing a non-DLT dose obtained from the dose escalation portion of IND 116117, NIH-NCI Grant (22.3 mCi (total 186RNL activity) at a concentration of 2.5 mCi/mL and 8.8 mL total volume).

Who Is Running the Clinical Trial?

Plus Therapeutics

Lead Sponsor

Trials

3

Recruited

110+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The novel rhenium compounds (PC1-6) demonstrated significant cytotoxicity against triple node negative breast cancer cell lines (HTB-132) in a 48-hour treatment study, indicating their potential as effective cancer treatments.

These rhenium compounds were found to be less nephrotoxic compared to cisplatin, suggesting a safer alternative for patients undergoing treatment for highly malignant breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anticancer Properties of Novel Rhenium Pentylcarbanato Compounds against MDA-MB-468(HTB-132) Triple Node Negative Human Breast Cancer Cell Lines. Parson, C., Smith, V., Krauss, C., et al.[2020]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

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

Rhenium-186 liposomes as convection-enhanced ...

We have also shown very promising results with rhenium-liposomes for the treatment of rat models of head and neck cancer11,15 and intraperitoneally ...

2.

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 ...

3.

jnm.snmjournals.org

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

Rhenium-186-NanoLiposome (186RNL) in the treatment of ...

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.

cancernetwork.com

cancernetwork.com/view/rhenium-obisbemeda-improves-survival-in-recurrent-glioblastoma

Rhenium Obisbemeda Improves Survival in Recurrent ...

Previous studies assessing glioblastoma have shown an average overall survival (OS) of about 8.5 months. However, results from the phase 1/2 ...

5.

jnm.snmjournals.org

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

Safety and Feasibility Results from a Phase 1/2 Clinical Trial ...

Conclusions: A single dose of by CED in adult patients with recurrent glioma achieves high absorbed doses without significant toxicity, is well tolerated, with ...

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.

journals.lww.com

journals.lww.com/neurosurgery/abstract/2025/04001/205_treatment_of_recurrent_glioblastoma__rgbm__via.95.aspx

205 Treatment of Recurrent Glioblastoma (rGBM) Via...

RESULTS: A single dose of 186RNL was well-tolerated with minimal systemic absorbed radiation dose exposure. No patient had treatment-related adverse events (AEs) ...