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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Rhenium (186Re) Obisbemeda (Rhenium-186 NanoLiposome, 186RNL), BMEDA-chelated-186rhenium encapsulated within liposomes, allows the 186Re to be directly delivered to the site of the tumor through CED and maintain localization at the site of infusion.
Maximum Tolerated Dose (MTD)
Determine the maximum tolerated dose (MTD) of 186RNL administered by convection-enhanced delivery (CED) in subjects with supratentorial recurrent, refractory, or progressive pediatric ependymoma or HGG.
Time frame: 28 days
Overall Response Rate (ORR) by RANO in Ependymoma
Determine the best overall response rate (ORR) by Radiographic Assessment in Neuro-Oncology (RANO) criteria following 186RNL administration in subjects with supratentorial recurrent, refractory, or progressive pediatric ependymoma.
Time frame: 90 days
Progression-Free Suvival at 12 months (PFS12) in HGG
Determine progression-free survival at 12 months (PFS12) in subjects with supratentorial recurrent, refractory, or progressive pediatric HGG.
Time frame: 12 months
Safety of 186RNL Dose
Assess the safety of single dose 186RNL administered by CED in subjects with supratentorial recurrent, refractory, or progressive pediatric ependymoma or HGG, as determined by the most recent version of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
Time frame: 28 days
Dose Distribution of 186RNL
Assess the dose distribution of 186RNL administered by CED in subjects with supratentorial recurrent, refractory, or progressive pediatric ependymoma or HGG.
Time frame: 8 days
Neuropsychologic Outcome
Assess the neuropsychologic outcomes of subjects exposed to 186RNL at 1 year in subjects with supratentorial recurrent, refractory, or progressive pediatric ependymoma or HGG using the following assessments. Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V; ages 6-16:11) OR Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-5; age \>17): Vocabulary, Block Design, Symbol Search, Coding, Digit Span California Verbal Learning Test, Children's Version (CVLT-C; ages 6-16:11) OR California Verbal Learning Test, Third Edition (CVLT-3; age \>17) Wide Range Assessment of Memory \& Learning, Third Edition (WRAML3; all ages): Story Memory, Design Learning Beery-Buktenica Developmental Test of Visual-Motor Integration (Beery VMI; all ages)
Time frame: 1 year
Progression-Free Survival at 24 Months (PFS24) in Ependymoma
Determine the progression-free survival at 24 months (PFS24) in subjects with supratentorial recurrent, refractory, or progressive pediatric ependymoma.
Time frame: 24 months
Overall Response Rate (ORR) by RANO in HGG
Determine the best overall response rate (ORR) by Radiographic Assessment in Neuro-Oncology (RANO) criteria following 186RNL administration in subjects with supratentorial recurrent, refractory, or progressive pediatric HGG.
Time frame: 90 days
Overall Survival at 24 Months (OS24)
Determine overall survival at 24 months (OS24) in participants with supratentorial recurrent, refractory, or progressive pediatric ependymoma and in participants with supratentorial recurrent, refractory, or progressive pediatric HGG.
Time frame: 24 months
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