Modified CV Regimen in Optic Pathway Glioma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age3-21
SponsorBeijing Sanbo Brain Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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 ≥1.5cm²;
KPS score ≥50 (age >12 years) or Lansky score ≥50 (age ≤12 years);
Disqualifiers
MRI examination is not available.
Failing to comply with the visual examination.
H3K27 mutations, even histopathological grade 1/2.
Receiving any other investigational agent.
Trial design
Design model
Single group
Treatments tested in this trial
Carboplatin
DrugDose 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
DrugDose 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
DrugRecombinant human endostatin (rh-ES) is administrated at a dose of 15mg daily, for 14 consecutive days every 3 weeks.
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: optic pathway gliomaExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
VA improvement rate
Percentage of visual acuity improvement
Time frame
up to 3 yearsSecondary outcomes
1
time to VA improvement
Time interval from the beginning of chemotherapy to VA improvement
Time frame
up to 3 years2
objective response rate
the percentage of patients who achieved confirmed complete response, partial response or minor response
Time frame
up to 3 years3
median time to response
Time interval from the beginning of chemotherapy to achieving complete response, partial response or minor response
Time frame
up to 3 yearsSponsors and contacts
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Source ClinicalTrials.gov