Actively Recruiting
Modified CV Regimen in Optic Pathway Glioma
Led by Beijing Sanbo Brain Hospital · Updated on 2024-10-15
75
Participants Needed
1
Research Sites
194 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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, disc swelling, and other visual/neurological problems. VA itself remains one of the most important outcome measures for OPG patients, with various studies showing strong ties of VA level to overall quality of life and well-being . Maintenance of favorable VA and vision outcomes is of paramount importance in the management of OPG. In terms of management of OPG, surgery and radiotherapy are used on a more limited basis because of location of the tumors and risk of secondary tumors, respectively. Tumor stabilization often prioritized, and chemotherapy is considered ideal for tumor stabilization in OPG, but vision is not always retained and may worsen in some cases, partially due to low radiographic efficacy and long time interval to response of the current chemotherapy regimen. In the prior study, the investigators modified the traditional carboplatin combined with vincristine regimen by increasing the dose of carboplatin and combining with an anti-angiogenic drug. Of the 15 OPG patients, objective response rate was 80% and the time to response was only 3.3 months. 8 (53%) patients experienced an improvement in visual acuity during therapy and 6 (40%) were stable, which was higher than the historical studies. This study was launched to further verify the clinical efficacy of the modified regimen and its effect on visual acuity improvement.
CONDITIONS
Official Title
Modified CV Regimen in Optic Pathway Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 3 months to 21 years
- Diagnosis of optic pathway glioma by histopathology or characteristic brain MRI and clinical features
- Measurable tumor lesion with less than 95% surgical removal or residual tumor area ≥1.5 cm²
- Karnofsky Performance Status (KPS) score ≥50 for age over 12 years or Lansky score ≥50 for age 12 years or younger
- Presence of clinical symptoms such as decreased visual acuity, visual field defects, optic disc edema, eye protrusion, increased intracranial pressure, or diencephalic syndrome
- No major organ dysfunction
You will not qualify if you...
- MRI examination not available
- Inability to comply with visual examination
- Presence of H3K27 mutations, regardless of tumor grade
- Receiving other investigational treatments
- History of allergic reactions to similar drugs
- History of organ transplantation
- Infection with HIV or syphilis (treponema pallidum)
- Serious cardiovascular disease or abnormal heart electrical activity
- Blood clotting disorders treated with blood thinners or recent significant bleeding events
- Recent arteriovenous thrombosis events within 6 months
- Pregnancy or breastfeeding
- Other conditions deemed unsuitable by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Capital Medical University Sanbo Brain Hospital
Beijing, China
Actively Recruiting
Research Team
J
Jun-ping Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here