55 Participants Needed

Rhenium Liposome Treatment for Brain Cancer

Recruiting at 3 trial locations
EG
LS
NL
EB
MM
AB
BT
RH
Overseen ByRachael Hershey
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Plus Therapeutics
Must be taking: Antiepileptics, Corticosteroids
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

AJ

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.
See 9 more

Exclusion Criteria

My tumor is 20 cm3 or smaller.
Evidence of acute intracranial or intratumoral hemorrhage
Unable or contraindicated to undergo MRI scan
See 8 more

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?
1Treatment groups
Experimental Treatment
Group I: 186Rhenium Liposome TreatmentExperimental Treatment1 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).

Find a Clinic Near You

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

Citations

Anticancer Properties of Novel Rhenium Pentylcarbanato Compounds against MDA-MB-468(HTB-132) Triple Node Negative Human Breast Cancer Cell Lines. [2020]
Liposomes loaded with a dirhenium compound and cisplatin: preparation, properties and improved in vivo anticancer activity. [2015]
Rhenium-186 liposomes as convection-enhanced nanoparticle brachytherapy for treatment of glioblastoma. [2021]
Characterization of the distribution, retention, and efficacy of internal radiation of 188Re-lipid nanocapsules in an immunocompromised human glioblastoma model. [2019]
A lipophilic complex with 186Re/188Re incorporated in liposomes suitable for radiotherapy. [2019]
Single dose acute toxicity testing for N,N-bis(2-mercaptoethyl)-N',N' diethylethylenediamine in beagles. [2014]
Dose Effect of Rhenium (I)-diselenoether as Anticancer Drug in Resistant Breast Tumor-bearing Mice After Repeated Administrations. [2017]
Dichlorotetra-mu-Isobutyratodirhenium(III): enhancement of cisplatin action and RBC-stabilizing properties. [2013]
External beam radiotherapy synergizes ¹⁸⁸Re-liposome against human esophageal cancer xenograft and modulates ¹⁸⁸Re-liposome pharmacokinetics. [2018]
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