Status:
RECRUITING
Modified CV Regimen in Optic Pathway Glioma
Lead Sponsor:
Beijing Sanbo Brain Hospital
Conditions:
Optic Glioma
Pediatric Brain Tumor, Optic Nerve Glioma
Eligibility:
All Genders
3-21 years
Phase:
PHASE2
Brief Summary
Optic pathway glioma (OPG) can result in visual deterioration. Symptomatic patients often report deficits in visual acuity (VA), visual field, visual-evoked potentials (VEPs), strabismus, proptosis, d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT05278715
Start Date
April 13 2022
End Date
December 31 2025
Last Update
October 15 2024
Active Locations (1)
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1
Capital Medical University Sanbo Brain Hospital
Beijing, China