Modified CV Regimen in Optic Pathway Glioma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	3 Months - 21 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05278715
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Beijing Sanbo Brain Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Optic Glioma, Pediatric Brain Tumor, Optic Nerve Glioma

Arms & Interventions

Arms

Experimental: optic pathway glioma

Interventions

Drug: - Carboplatin

Dose of carboplatin is adjusted for age (over 1 year old, full dose, 220 mg/m^2; 6 months of age or less, 66 percent of the full dose; 7 to 12 months of age, 80 percent).

Drug: - Vincristine

Dose of vincristine is adjusted for age (over 1 year old, full dose, 1.5 mg/m^2; 6 months of age or less, 66 percent of the full dose; 7 to 12 months of age, 80 percent). Maximum dose is 2 mg.

Drug: - Recombinant human endostatin

Recombinant human endostatin (rh-ES) is administrated at a dose of 15mg daily, for 14 consecutive days every 3 weeks.

Contact a Trial Team

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International Sites

Beijing, China

Status

Recruiting

Address

Capital Medical University Sanbo Brain Hospital

Beijing, ,

Site Contact

Jun-ping Zhang

[email protected]

86-010-62856783

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