Recruiting PHASE2 Optic Glioma

New treatment option for Optic Glioma

Official title Modified CV Regimen in Optic Pathway Glioma

ClinicalTrials.gov ID: NCT05278715

What this study is testing

What is Carboplatin?

Carboplatin is an investigational medicine, being studied as a potential treatment for optic glioma.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 3 to 21

You may be able to join if

  • 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...

You likely can't join if

  • 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.
See the full eligibility criteria
Who can join
  • 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.
What rules you out
  • 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...
  • Pregnant or breastfeeding.
  • Other conditions considered inappropriate by the researcher for inclusion.

The study team makes the final eligibility decision.

Where it's taking place

  • Beijing, China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 3 months to 21 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.