Modified CV Regimen in Optic Pathway Glioma

Last updated: October 9, 2024
Sponsor: Beijing Sanbo Brain Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Neurofibromatosis

Cancer/tumors

Astrocytoma

Treatment

Carboplatin

Recombinant human endostatin

Vincristine

Clinical Study ID

NCT05278715
首发-2022-2-8012
  • Ages 3-21
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 3months and ≤21years;

  • Patients with optic pathway gliomas diagnosed by histopathology or characteristicbrain 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 discedema, exophthalmia, increased intracranial pressure, diencephalic syndrome, etc;

  • No dysfunction of major organs.

Exclusion

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 orbiologic 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 STsegment changes.

  • Patients who had coagulation disorder and were being treated with thrombolytic oranticoagulant drugs. Patients with significant clinical bleeding symptoms or clearbleeding tendency occurred within 3 months before enrollment, such asgastrointestinal bleeding, hemorrhagic gastric ulcer, gastrointestinal perforation,baseline fecal occult blood ++ or above, intratumoral or intracranial bleeding, orvasculitis, 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 beforeenrollment.

  • Pregnant or breastfeeding.

  • Other conditions considered inappropriate by the researcher for inclusion.

Study Design

Total Participants: 75
Treatment Group(s): 3
Primary Treatment: Carboplatin
Phase: 2
Study Start date:
April 13, 2022
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Capital Medical University Sanbo Brain Hospital

    Beijing,
    China

    Active - Recruiting

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