ArticleNeuro-oncology2025
Phase 1 dose-escalation trial using convection-enhanced delivery of radio-immunotheranostic 124I-Omburtamab for diffuse intrinsic pontine glioma.
Article in Neuro-oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT01502917 (A Phase I Study of Convection-Enhanced Delivery of 124I-Omburtamab for Patients With Non-Progressive Diffuse Pontine Gliomas Previously Treated With External Beam Radiation Therapy), which is not on this map. Cited by 13 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase I Study of Convection-Enhanced Delivery of 124I-Omburtamab for Patients With Non-Progressive Diffuse Pontine Gliomas Previously Treated With External Beam Radiation Therapy
Who cites it
13 citing papers in PubMed.
- Radioligand therapy for pediatric patients with solid tumors.The British journal of radiology · 2026Review
- Preclinical Activity of the B7-H3-Targeting Antibody-Drug Conjugate Vobramitamab Duocarmazine in Pediatric Solid Tumors.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Article
- Diffuse Midline Gliomas: Clinical, Diagnostic, and Therapeutic Perspectives.Biomedicines · 2026Review
- B7-H3 (CD276): an actionable therapeutic target and prognostic biomarker across human malignancies.Frontiers in immunology · 2026Review
- Engineered nanomedicine remodels the postoperative cavity microenvironment to suppress glioblastoma recurrence.Theranostics · 2026Review
- Transcriptomics-guided high-throughput drug screening identifies potent therapies for P53 pathway altered DIPG/DMG.Neuro-oncology · 2026Article
- Evaluation on the efficacy and safety of CyberKnife stereotactic radiotherapy for brainstem gliomas.Frontiers in oncology · 2026Article
- Adaptive immunotherapeutic paradigms in diffuse midline glioma: integrating epigenetic reprogramming, neuron-glioma interactions, and tumor microenvironment modulation.Journal of neuro-oncology · 2025Review
- Emerging frontiers in diffuse intrinsic pontine glioma treatment: A new hope.Neuro-oncology · 2025Article
- Targeting the CD40 costimulatory receptor to improve virotherapy efficacy in diffuse midline gliomas.Cell reports. Medicine · 2025Article
- From Seeing to Healing: The Clinical Potential of Radiotracers in Pediatric Neuro-Oncology.Cancers · 2025Review
- Overcoming the blood-brain barrier: targeted delivery strategies for gliomas.Frontiers in pharmacology · 2025Review
- Patterns of relapse in diffuse intrinsic pontine glioma after convection-enhanced delivery ofNeuro-oncology advancesArticle
Corrections and comments
- Commented on by
- Erratum issued
Authors and funding
16 authors.
Funding
Abstract
backgroundMedian survival for patients with Diffuse Intrinsic Pontine Glioma (DIPG) is 8-12 months.
methodsA phase 1, open label, 3 + 3 dose-escalation trial delivered radiolabeled 124I-Omburtamab, targeting B7-H3, using MR-guided stereotactic convection-enhanced delivery (CED) into the brainstem of pediatric DIPG patients. CED was performed after completion of standard-of-care external-beam radiation therapy (EBRT). Fifty children were treated and evaluable. 124I-Omburtamab activity was escalated from 0.25 to 10.0 mCi (9.25-370 MBq) and volume escalated from 0.25 mL to 10.0 mL with serial PET/MRI post administration. Safety was the primary outcome. National Cancer Institute Common Terminology Criteria for Adverse Events were assessed for 30 days following CED of 124I-Omburtamab. Secondary outcomes included overall survival and lesion-to-whole-body absorbed dose ratio.
resultsThe maximum tolerated activity per study protocol was determined to be 6mCi (222 MBq). The overall mean (±SD) total absorbed dose in the lesion per unit injected activity was 35.2 ± 18 cGy/MBq with a high lesion-to-whole-body absorbed dose ratio averaging 816, across all activity levels. Eleven patients had treatment-related grade 3 CNS toxicities with no grade-4 or -5 CNS toxicities. Five dose-limiting toxicity events occurred. Median survival was 15.29 months from diagnosis (95% CI: 12.20-16.83 months). Survival rate estimates at 1, 2, and 3 years were 65.4% (CI 53.3-80.1%), 18.4% (CI: 10.2-33.2%), and 11.7% (CI: 5.3-25.7%), respectively.
conclusionsAdministration of 124I-Omburtamab via CED is a safe treatment option for DIPG, with a maximum tolerated activity level identified. This study represents the first-in-human theranostic use of a 124I radiopharmaceutical, simultaneously, as an imaging and therapeutic agent.
trial registrationNCT01502917; https://clinicaltrials.gov/study/NCT01502917.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.