Actively Recruiting
Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT)
Led by Plus Therapeutics · Updated on 2025-03-26
55
Participants Needed
3
Research Sites
547 weeks
Total Duration
On this page
Sponsors
P
Plus Therapeutics
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age.
- Able to understand the study and provide informed consent.
- Histologically confirmed Grade III or IV recurrent glioma.
- Evidence of tumor progression after standard treatments or medically unable/unwilling to follow standard treatments.
- Stable dose of antiepileptic medication for at least two weeks without seizures.
- Stable or decreasing corticosteroid dose for at least two weeks with no worsening symptoms.
- Tumor located within the treatment field volume.
- ECOG performance status 0 to 2; Karnofsky score 60 or higher.
- Life expectancy of at least 2 months.
- Acceptable liver function: bilirubin ≤ 1.5 times normal; AST and ALT ≤ 3 times normal.
- Acceptable kidney function: serum creatinine ≤ 1.5 times normal.
- Acceptable blood counts without support: ANC ≥ 1000 cells/uL; platelets ≥ 100,000/uL; hemoglobin ≥ 9.0 g/dL.
- Women of childbearing potential must have a negative pregnancy test and all participants must agree to use effective contraception during and for 6 months after the study.
You will not qualify if you...
- Acute intracranial or intratumoral hemorrhage seen on MRI or CT, except resolving or minor hemorrhages.
- Unable or medically unsuitable for MRI.
- Not recovered to Grade 1 or better from prior treatment side effects (except alopecia, anemia, lymphopenia).
- Pregnant or breastfeeding.
- Serious illnesses such as uncontrolled hypertension, active infections, significant heart arrhythmias, untreated hypothyroidism, recent heart failure or stroke, or other active cancers.
- Bleeding disorders or high risk of bleeding.
- Prior treatments including Bevacizumab, certain radiation therapies within 12 weeks, recent systemic or biologic therapies, or investigational agents within defined time frames.
- Multifocal tumor progression or leptomeningeal involvement.
- Psychiatric or social conditions limiting study compliance.
- Tumors located infratentorially or within 1-2 cm of a ventricle posing risk for drug leakage.
- For Phase 2: tumor volume greater than 20 cm3.
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Northshore University Hospital
Manhasset, New York, United States, 11030
Actively Recruiting
2
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
3
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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