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Modified CV Regimen in Optic Pathway Glioma

Primary Purpose

Optic Glioma, Pediatric Brain Tumor, Optic Nerve Glioma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Carboplatin
Vincristine
Recombinant human endostatin
Sponsored by
Beijing Sanbo Brain Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Optic Glioma

Eligibility Criteria

3 Months - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Capital Medical University Sanbo Brain HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

optic pathway glioma

Arm Description

Outcomes

Primary Outcome Measures

VA improvement rate
Percentage of visual acuity improvement

Secondary Outcome Measures

time to VA improvement
Time interval from the beginning of chemotherapy to VA improvement
objective response rate
the percentage of patients who achieved confirmed complete response, partial response or minor response
median time to response
Time interval from the beginning of chemotherapy to achieving complete response, partial response or minor response

Full Information

First Posted
February 17, 2022
Last Updated
July 20, 2023
Sponsor
Beijing Sanbo Brain Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05278715
Brief Title
Modified CV Regimen in Optic Pathway Glioma
Official Title
Clinical Study of Modified Carboplatin/Vincristine Chemotherapy Regimen for Visual Function Protection in Children With Optic Pathway Gliomas
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Sanbo Brain Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Optic Glioma, Pediatric Brain Tumor, Optic Nerve Glioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
optic pathway glioma
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
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
Intervention Name(s)
Vincristine
Intervention Description
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
Intervention Name(s)
Recombinant human endostatin
Intervention Description
Recombinant human endostatin (rh-ES) is administrated at a dose of 15mg daily, for 14 consecutive days every 3 weeks.
Primary Outcome Measure Information:
Title
VA improvement rate
Description
Percentage of visual acuity improvement
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
time to VA improvement
Description
Time interval from the beginning of chemotherapy to VA improvement
Time Frame
up to 3 years
Title
objective response rate
Description
the percentage of patients who achieved confirmed complete response, partial response or minor response
Time Frame
up to 3 years
Title
median time to response
Description
Time interval from the beginning of chemotherapy to achieving complete response, partial response or minor response
Time Frame
up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun-ping Zhang
Phone
86-010-62856783
Email
doczhjp@hotmail.com
Facility Information:
Facility Name
Capital Medical University Sanbo Brain Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun-ping Zhang
Phone
86-010-62856783
Email
doczhjp@hotmail.com

12. IPD Sharing Statement

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Modified CV Regimen in Optic Pathway Glioma

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