Modified CV Regimen in Optic Pathway Glioma

NCT05278715 | Recruiting Phase 2

• 1 other identifier: 首发-2022-2-8012
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• VA improvement rate

  Percentage of visual acuity improvement

  up to 3 years

Secondary Outcomes (3)

• time to VA improvement

  up to 3 years

• objective response rate

  up to 3 years

• median time to response

  up to 3 years

Study Arms (1)

optic pathway glioma

EXPERIMENTAL

Drug: Carboplatin; Drug: Vincristine; Drug: Recombinant human endostatin

Interventions

Carboplatin 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).

optic pathway glioma

Vincristine 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.

optic pathway glioma

Recombinant human endostatin DRUG

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

optic pathway glioma

Eligibility Criteria

• Age: 3 Months - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify 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 syndrome, etc;
• No dysfunction of major organs.

You may not qualify 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.
• 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.

Sponsors & Collaborators

• Beijing Sanbo Brain Hospital: lead

Study Sites (1)

Capital Medical University Sanbo Brain Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Optic Nerve Glioma

Interventions

Carboplatin; Vincristine; Endostatins

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Optic Nerve Neoplasms; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Cranial Nerve Diseases; Nervous System Diseases; Optic Nerve Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Angiostatic Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins; Biological Factors

Central Study Contacts

Jun-ping Zhang

CONTACT

86-010-62856783; doczhjp@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: March 14, 2022
• Study Start: April 13, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)