Rhenium Liposome Treatment for Brain Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a multi-center, sequential cohort, open-label, volume and dose escalation study of the safety, tolerability, and distribution of 186RNL given by convection enhanced delivery to patients with recurrent or progressive malignant glioma after standard surgical, radiation, and/or chemotherapy treatment. The study uses a modified Fibonacci dose escalation, followed by an expansion at the maximum tolerated dose (MTD) to determine efficacy. The starting absorbed dose is 1mCi in a volume of 0.660mL.
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 Rhenium Liposome Treatment safe for humans?
Studies on Rhenium-186 liposomes in rats showed no signs of toxicity even at high doses, and a related compound, (188)Re-BMEDA-liposome, was found safe in beagles at certain doses. These findings suggest that Rhenium Liposome Treatment may be generally safe, but more research is needed to confirm its safety in humans.12345
How is Rhenium Liposome Treatment different from other brain cancer treatments?
Rhenium Liposome Treatment is unique because it uses liposomally encapsulated radionuclides, specifically rhenium-186, delivered directly to the brain tumor site through convection-enhanced delivery. This method allows for high doses of radiation to be administered locally without significant toxicity, potentially improving survival compared to standard treatments.12567
What data supports the effectiveness of the Rhenium Liposome Treatment for brain cancer?
Research shows that Rhenium-186 liposomes, when used in a specific delivery method, significantly increased survival in a rat model of brain cancer compared to controls, without causing noticeable toxicity. Additionally, another study found that a similar Rhenium-based treatment led to long-term survival in a human brain cancer model, suggesting its potential effectiveness.12689
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase I Treatment
Participants receive a single dose of 186RNL through convection enhanced delivery, with dose escalation to determine the maximum tolerated dose
Phase II Treatment
Participants receive a non-DLT dose of 186RNL determined from Phase I, administered through convection enhanced delivery
Follow-up
Participants are monitored for safety, efficacy, and progression-free survival after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Rhenium Liposome Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Plus Therapeutics
Lead Sponsor
National Cancer Institute (NCI)
Collaborator