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RECRUITING
NCT05278715
PHASE2

Modified CV Regimen in Optic Pathway Glioma

Sponsor: Beijing Sanbo Brain Hospital

View on ClinicalTrials.gov

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, 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.

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

Key Details

Gender

All

Age Range

3 Months - 21 Years

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2022-04-13

Completion Date

2025-12-31

Last Updated

2024-10-15

Healthy Volunteers

No

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.

Locations (1)

Capital Medical University Sanbo Brain Hospital

Beijing, China