Actively Recruiting
Safety & Efficacy/Tolerability of Rhenium-186 NanoLiposomes (186RNL) for Patients Who Received a Prior 186RNL Treatment
Led by Plus Therapeutics · Updated on 2025-03-30
40
Participants Needed
1
Research Sites
167 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 (via intraventricular catheter) for recurrence glioma in patients who received a prior treatment of 186RNL.
CONDITIONS
Official Title
Safety & Efficacy/Tolerability of Rhenium-186 NanoLiposomes (186RNL) for Patients Who Received a Prior 186RNL Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age at time of screening.
- Able to understand study purposes and risks and provide informed consent.
- Biopsy and histology confirmed glioma following prior 186RNL treatment, Grades III and IV.
- At least 90 days since prior 186RNL dose at screening.
- Stable dose of antiepileptic medications for at least two weeks without seizures.
- Stable or decreasing corticosteroid dose for at least two weeks without worsening symptoms.
- Tumor volume within the treatment field volume per cohort.
- ECOG performance status 0 to 2; ECOG 3 acceptable with investigator approval.
- Life expectancy of at least 2 months.
- Acceptable liver function: Bilirubin ≤1.5x ULN; AST and ALT ≤3.0x ULN.
- Acceptable renal function: Serum creatinine ≤1.5x ULN.
- Acceptable blood counts without support: ANC ≥1000 cells/µL; Platelets ≥100,000/µL if no bleeding; Hemoglobin ≥7.0 g/dL.
- Women of childbearing potential must have negative pregnancy test and agree to use contraception during study and for 6 months after last dose.
- Malignant glioma progressed after standard treatment and planned stereotactic biopsy as standard care.
You will not qualify if you...
- Acute intracranial or intratumoral hemorrhage on MRI or CT (except resolving or punctate hemorrhage).
- Contraindications to CNS MRI.
- Not recovered to Grade ≤1 adverse events from prior treatments (except alopecia, anemia, lymphopenia).
- Pregnant or breastfeeding.
- Serious illnesses compromising safety including uncontrolled hypertension, non-healing wounds, significant cardiac arrhythmias, untreated hypothyroidism, systemic infection, recent heart failure, recent myocardial infarction or stroke, or active malignancy other than glioma.
- Inherited bleeding disorders with bleeding risk.
- Prior anticancer therapies such as non-standard radiation, recent CNS radiation, recent systemic or biologic therapy, prior carmustine wafers, or current investigational treatments.
- Multifocal progression or leptomeningeal involvement.
- Psychiatric or social issues limiting compliance.
- Infratentorial disease unless approved by investigators.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Cancer Therapy and Research Center at UTHSCSA
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
R
Rachael Hershey
CONTACT
A
Andrew Brenner, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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