Treatment for optic pathway glioma in children and young adults

Clinical Study of Modified Carboplatin/vincristine Chemotherapy Regimen for Visual Function Protection in Children with Optic Pathway Gliomas

This study is testing a new combination of chemotherapy drugs to see if it can help children and young adults with optic pathway glioma keep their vision and improve their quality of life.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 3 Months to 21 Years
• Sex: All
• Sponsor: Beijing Sanbo Brain Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT05278715 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates a modified chemotherapy regimen using Carboplatin, Vincristine, and Recombinant human endostatin for patients with optic pathway glioma (OPG). The focus is on stabilizing the tumor while preserving visual acuity and overall quality of life, as OPG can lead to significant visual deterioration. Eligible participants include children and young adults aged 3 months to 21 years with measurable lesions and specific clinical symptoms. The study aims to assess the efficacy of this treatment approach in maintaining favorable vision outcomes.

Who should consider this trial

Good fit: Ideal candidates are children and young adults aged 3 months to 21 years diagnosed with optic pathway gliomas and experiencing visual deficits.

Not a fit: Patients with H3K27 mutations or those who have received organ transplants may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could help preserve vision and improve quality of life for patients with optic pathway glioma.

How similar studies have performed: Other studies have shown promise in using chemotherapy for optic pathway gliomas, but this specific regimen is novel.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 3months and ≤21years;
* Patients with optic pathway gliomas diagnosed by histopathology or characteristic brain MRI and clinical features;
* Measurable lesions, surgical resection degree \< 95% or postoperative residual tumor ≥1.5cm\^2;
* KPS score ≥50 (age \>12 years) or Lansky score ≥50 (age ≤12 years);
* Clinical symptoms such as decreased visual acuity, visual field defect, optic disc edema, exophthalmia, increased intracranial pressure, diencephalic syndrome, etc;
* No dysfunction of major organs.

Exclusion Criteria:

* MRI examination is not available.
* Failing to comply with the visual examination.
* H3K27 mutations, even histopathological grade 1/2.
* Receiving any other investigational agent.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the drugs used in this study.
* Patients who have received organ transplants.
* Patients infected with HIV or treponema pallidum.
* Suffering from serious cardiovascular disease;T wave inversion or elevation or ST segment changes.
* Patients who had coagulation disorder and were being treated with thrombolytic or anticoagulant drugs. Patients with significant clinical bleeding symptoms or clear bleeding tendency occurred within 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, gastrointestinal perforation, baseline fecal occult blood ++ or above, intratumoral or intracranial bleeding, or vasculitis, etc. Arteriovenous thrombosis events (such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage and cerebral infarction), deep vein thrombosis and pulmonary embolism) occurred within 6 months before enrollment.
* Pregnant or breastfeeding.
* Other conditions considered inappropriate by the researcher for inclusion.

Where this trial is running

Beijing

• Capital Medical University Sanbo Brain Hospital — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Jun-ping Zhang

Conditions: Optic Glioma, Pediatric Brain Tumor, Optic Nerve Glioma