TheranosticTrials.org
Oranomed

Clinical Trial · NCT07061626

Determine Maximum Tolerated Dose, Safety, and Tolerability of Rhenium (186Re) in Pediatric Recurrent, Refractory or Progressive Ependymoma and High-Grade Glioma

Overview

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.

Sponsor

Oranomed

Phase

Phase 1

ClinicalTrials.gov

NCT07061626

Eligibility

Inclusion

  • Platelet count ≥100,000/uL
  • Lesion number and size:
  • Acceptable liver function:
  • 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: a) Documented recurrent, refractory, or progressive ependymoma or HGG not eligible for resection or no longer receiving standard of care. i) Phase 2a only: May include patients with recurrent, refractory, or progressive ependymoma or HGG where SOC surgery could be safely delayed four (4) weeks post-infusate. b) Documented histologically confirmed high-grade glioma \[following 2021 WHO CNS5 glioma nomenclature, e.g., Anaplastic astrocytoma, Anaplastic pleomorphic xanthoastrocytoma (PXA), Anaplastic ganglioglioma, Anaplastic oligodendroglioma, Glioblastoma, Diffuse midline glioma, H3K27M mutant\].
  • AST (SGOT) and ALT (SGPT) ≤ 3.0 times the upper limit of normal (ULN) 6\) Acceptable renal function: <!-- -->
  • Bilirubin ≤ 1.5 times the upper limit of normal
  • Serum creatinine ≤1.5xULN7\. Acceptable hematologic status (without hematologic support):
  • ANC ≥1000 cells/uL
  • 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).

Exclusion

  • Involvement of the leptomeninges.
  • Psychiatric illness/social situations that would limit compliance with the study requirements.
  • Inherited bleeding diathesis or coagulopathy with the risk of bleeding.
  • Evidence of acute intracranial or intratumoral hemorrhage either by magnetic resonance imaging (MRI) or computerized tomography (CT) scan (subjects with resolving hemorrhage changes, punctate hemorrhage, or hemosiderin are eligible).
  • Known active malignancy other than ependymoma or high-grade glioma.
  • Untreated hypothyroidism.
  • Nitrosoureas or mitomycin C within 42 days prior to study registration.
  • Myocarditis.
  • Prior treatment with Bevacizumab or other VEGF agents within 12 months prior to study registration.
  • Patients with corticosteroid requirements to control cerebral edema must be maintained at a stable or decreasing dose for a minimum of two weeks without progression of clinical symptoms prior to study registration.
  • A tumor located within 1.0cm of a ventricle AND it is determined by the surgeon, PI, and Sponsor to be a risk for drug extravasation to the subarachnoid space if given catheter placement and drug administration.
  • A tumor within 1.5cm of critical structures, including the optic chiasm, optic nerves, or brainstem.
  • Any systemic therapy within 28 days or 2 half-lives, whichever is longer, prior to study registration (this may include investigational agents, small-molecule kinase inhibitors, non-cytotoxic hormonal therapy, biologic agents, metronomic/protracted low-dose chemotherapy, etc.).
  • Treatment with antiepileptic medications must have a two-week history of a stable dose of antiepileptic without seizures prior to study registration.
  • Any of the following prior anticancer therapy:
  • Active medically significant infection unresponsive to antibiotics (e.g., non-healing wound, ulcer), uncontrolled systemic infection, or bone fracture.
  • Non-standard radiation therapy such as brachytherapy, systemic radioisotope therapy, or intra-operative radiotherapy (IORT) to the target site at any time prior to study registration.
  • Spinal disease.
  • Serious intercurrent illness, as determined by the treating physician, which would compromise either patient safety or study outcomes such as:
  • Congestive heart failure.
  • Clinically significant cardiac arrhythmias.
  • Infratentorial location of tumor.
  • Standard radiation therapy within 12 weeks prior to study registration.

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