Modified CV Regimen in Optic Pathway Glioma

NCT ID: NCT05278715

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-13
• Study Completion Date: 2025-12-31

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, 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

Optic Glioma; Pediatric Brain Tumor, Optic Nerve Glioma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

optic pathway glioma

Group Type: EXPERIMENTAL

Carboplatin

Intervention Type: DRUG

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).

Vincristine

Intervention Type: DRUG

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.

Recombinant human endostatin

Intervention Type: DRUG

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

Interventions

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).

Intervention Type: 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.

Intervention Type: DRUG

Recombinant human endostatin

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Sanbo Brain Hospital

OTHER

Sponsor Role: lead

Responsible Party

Junping Zhang

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Capital Medical University Sanbo Brain Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jun-ping Zhang

Role: CONTACT

doczhjp@hotmail.com

86-010-62856783

Facility Contacts

Jun-ping Zhang

Role: primary

doczhjp@hotmail.com

86-010-62856783

Other Identifiers

首发-2022-2-8012

Identifier Type: -

Identifier Source: org_study_id