Optic GliomaPhase 2NCT05278715
Modified CV Regimen in Optic Pathway Glioma
A Phase 2 study testing Carboplatin, Vincristine and Recombinant human endostatin in people with Optic Glioma and Pediatric Brain Tumor, Optic Nerve Glioma, run by Beijing Sanbo Brain Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 21 years
- Conditions the study is for
- Optic Glioma, Pediatric Brain Tumor, Optic Nerve Glioma
- What is being tested?
- Carboplatin, Vincristine and Recombinant human endostatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 13 Apr 2022to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Capital Medical University Sanbo Brain Hospital
Beijing
Jun-ping Zhang, 86-010-62856783, doczhjp@hotmail.com
About this study
Official title: Clinical Study of Modified Carboplatin/vincristine Chemotherapy Regimen for Visual Function Protection in Children with Optic Pathway Gliomas
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.
Read more
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.
- Being tested
- Carboplatin, Vincristine, Recombinant human endostatin
- Medical subject headings
- Optic Nerve Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
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).
VincristineDrug
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 endostatinDrug
Recombinant human endostatin (rh-ES) is administrated at a dose of 15mg daily, for 14 consecutive days every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| optic pathway glioma | Experimental | Not described Receives: Drug: Carboplatin; Drug: Vincristine; Drug: Recombinant human endostatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
VA improvement rate
Percentage of visual acuity improvement
Measured: up to 3 years
Secondary outcomes (3)
time to VA improvement
Time interval from the beginning of chemotherapy to VA improvement
Measured: up to 3 years
objective response rate
the percentage of patients who achieved confirmed complete response, partial response or minor response
Measured: up to 3 years
median time to response
Time interval from the beginning of chemotherapy to achieving complete response, partial response or minor response
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start13 Apr 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Sanbo Brain Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junping Zhang, Beijing Sanbo Brain Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278715
- Sponsor's protocol ID
- 首发-2022-2-8012
- Status last verified
- Oct 2024
- First submitted
- 17 Feb 2022
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Modified Carboplatin/vincristine Chemotherapy Regimen for Visual Function Protection in Children with Optic Pathway Gliomas
- ClinicalTrials.gov ID
- NCT05278715
- Acronym / sponsor ID
- 首发-2022-2-8012
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Beijing Sanbo Brain HospitalUniversity, hospital or other
- Study start
- 13 Apr 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| optic pathway glioma | Experimental | Drug: Carboplatin, Drug: Vincristine, Drug: Recombinant human endostatin |
Who may qualify
- Ages
- 3 months to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarboplatinDose 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). | Drug | optic pathway glioma |
| VincristineDose 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. | Drug | optic pathway glioma |
| Recombinant human endostatinRecombinant human endostatin (rh-ES) is administrated at a dose of 15mg daily, for 14 consecutive days every 3 weeks. | Drug | optic pathway glioma |
Primary outcome
VA improvement rate
Time frame: up to 3 years
Percentage of visual acuity improvement
3 secondary outcomes
time to VA improvement
Time frame: up to 3 years
objective response rate
Time frame: up to 3 years
median time to response
Time frame: up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carboplatin, Vincristine and Recombinant human endostatin in people with Optic Glioma and Pediatric Brain Tumor, Optic Nerve Glioma, run by Beijing Sanbo Brain Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun-ping Zhang (86-010-62856783, doczhjp@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VA improvement rate (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.