Determine Maximum Tolerated Dose, Safety, and Tolerability of Rhenium (186Re) in Pediatric Recurr… (NCT07061626) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Determine Maximum Tolerated Dose, Safety, and Tolerability of Rhenium (186Re) in Pediatric Recurrent, Refractory or Progressive Ependymoma and High-Grade Glioma
56 participantsStarted 2025-09
Plain-language summary
Pediatric patients 6-21 years of age with supratentorial recurrent, refractory, or progressive pediatric ependymoma and high-grade glioma (HGG) will be included in this study of treatment with Rhenium-186 Nanoliposome (186RNL). Phase 1 of the study will look to determine the maximum tolerated dose (MTD) of 186RNL in this patient population. Phase 2 of the study will use the recommended dose determined in Phase 1 to continue to look at overall response rate and progression-free survival following 186RNL treatment.
Who can participate
Age range6 Years – 21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 6 years to 21 years\* of age.
✓. Lesion number and size:
✓. Phase 1a/b only: A single lesion (less than or equal to) ≤3.5 cm (longest axis) and volume of (less than or equal to) ≤22.4 mL as the largest tumor (subsequent to individual Cohort lesion size requirements).
✓. Phase 2a only: A single lesion or any number of multiple lesions separated by (less than or equal to) ≤3 cm; each lesion (less than or equal to) ≤3.5 cm (longest axis) and volume of (less than or equal to) ≤22.4 mL as the largest tumor.
✓. Diagnosis:
✓. Karnofsky Performance Status ≥ 60. For subjects \<16 years of age, Lansky score ≥ 60.
✓. Acceptable liver function:
✓. Bilirubin ≤ 1.5 times the upper limit of normal
Exclusion criteria
✕. Spinal disease.
✕. Infratentorial location of tumor.
✕. Involvement of the leptomeninges.
✕. Serious intercurrent illness, as determined by the treating physician, which would compromise either patient safety or study outcomes such as:
✕. Hypertension (two or more blood pressure readings performed at screening of systolic blood pressure (SBP) or diastolic blood pressure (DBP) above 95th percentile for age) despite optimal treatment.
What they're measuring
1
Maximum Tolerated Dose (MTD)
Timeframe: 28 days
2
Overall Response Rate (ORR) by RANO in Ependymoma
Timeframe: 90 days
3
Progression-Free Suvival at 12 months (PFS12) in HGG
✕. Active medically significant infection unresponsive to antibiotics (e.g., non-healing wound, ulcer), uncontrolled systemic infection, or bone fracture.