Low-grade GliomaPhase 2NCT04659421

Study of Recombinant Human Endostatin Combined With CV Regimen in the Treatment of Pediatric Low-grade Gliomas

A Phase 2 study testing combined therapy with rh-ES and CV in people with Low-grade Glioma and Pediatric Brain Tumor, run by Beijing Sanbo Brain Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Low-grade gliomas (LGGs) are the most common intracranial tumors in children, accounting for about 40% of intracranial tumors in children. The biological characteristics and clinical prognosis of LGGs vary greatly, and they can present different biological characteristics such as restricted growth, invasive growth… Read more about this study

Who is it for?: Ages 3 months to 18 years
Conditions the study is for: Low-grade Glioma, Pediatric Brain Tumor
What is being tested?: combined therapy with rh-ES and CV
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteChina
Study dates: 3 Nov 2020to 20 Jul 2023
Phase: Phase 2
Are there results?: None posted in the registry

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 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Age ≥ 3months and ≤18years;
Histopathologically confirmed low-grade glioma (WHO grade I and II), including astrocytoma, pilocytic astrocytoma, pleomorphic xanthoastrocytoma, subependymal giant cell astrocytoma, infantile desmoplastic astrocytoma, low-grade oligodendroglioma, oligoastrocytoma, ganglioglioma, and infantile desmoplastic ganglioglioma. Chiasmatic-hypothalamic tumors intrinsic to the optic pathway were eligible without pathologic confirmation.
There is a clear evaluable lesion with less than 95% resection or residual tumor of more than 1.5 cm^2；
KPS score ≥50 (age> 12 years old) or Lansky score ≥ 50 (age ≤ 12 years old)；
Estimated survival of at least 12 weeks;
Have not been received radiotherapy or chemotherapy before；

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Participants must have adequate organ function as defined by the following criteria (within 7 days before treatment):
Hematology (No transfusion within 14 days):
Hemoglobin(HB)≥90g/L; Absolute neutrophil count (ANC)≥1.5×10^9/L; Platelet (PLT)≥80×10^9/L.
Chemistry:
Serum bilirubin ≤ 1.5×upper limit of normal (ULN) ALT and AST≤2.5ULN； Serum creatinine ≤1.5ULN or creatinine clearance rate(CCr)≥60ml/min； ECG: heart rate in the normal range (55-100beats/min), normal or slightly prolonged QT interval (QTc<480ms), normal or low T wave, normal or non-specific ST segment changes；
The patient or his legal guardian signs an informed consent form.

Who cannot join

MRI examination is not available;
Diffuse intrinsic pontine glioma or diffuse midline glioma with H3K27 mutation, even though the histopathology is grade I/II;
Non-glial low-grade rare intracranial tumors;
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 with HIV or Treponema pallidum infection;
Severe heart disease; ECG shows T wave inversion or elevation or ST segment specific changes;
There were clinically significant bleeding symptoms or clear bleeding tendency in the first 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, gastrointestinal perforation, baseline fecal occult blood ++ and above, intracranial or intracranial hemorrhage, or vasculitis;
Arteriovenous thrombosis events occurred within 6 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.;
Having bleeding disorder and are being treated with thrombolytic or anticoagulant drugs.
Patients who are pregnant or breastfeeding.
Other conditions considered inappropriate by the researcher for inclusion.

Trial locations and contacts

1 site in 1 country.

China1 site

Capital Medical University Sanbo Brain Hospital
Beijing

Other trials in China

About this study

Official title: A Prospective, Singal-arm Clinical Study of Recombinant Human Endostatin (ENDOSTAR) Combined With Carboplatin and Vincristine in the Treatment of Low-grade Gliomas in Children

For LGGs, surgical resection is the main treatment method. However, many tumors located in the visual pathway, brainstem, hypothalamus and other midline parts, it is impossible to completely remove. Radiotherapy can effectively control tumor progression to a certain extent, but radiotherapy can cause obvious and serious delayed damage, such as cognitive impairment, endocrine disorders, cerebrovascular events, and second tumors. Chemotherapy can effectively treat LGGs in children, and can postpone or avoid radiotherapy. It is the preferred treatment for children with LGGs after surgery. Carboplatin combined with vincristine, the CV regimen, is currently the main chemotherapy regimen for the treatment of children with LGGs.

Anti-angiogenesis is a new type of treatment. Bevacizumab, a humanized monoclonal antibody that targets vascular endothelial growth factor (VEGF). Among children with relapsed, refractory or progressing LGGs, the effective rate of Bev combined with irinotecan was 44%, and the 6-month and 2-year progression-free survival rates were 85% and 48%, respectively. However, almost all of them were treated with Bev progressed again. Tumor growth is more aggressive after Bev treatment fails. Recombinant human endostatin (rh-ES) is an endogenous broad-spectrum angiogenesis inhibitor that has been shown to significantly improve therapeutic efficacy when combining with conventional chemotherapy agents in non-small-cell lung cancer, breast cancer and melanoma.Previous retrospective studies of the research team found that rh-ES combined with CV can treat LGGs in children effectively, shorten the onset time, help quickly alleviate the symptoms of brainstem damage, and improve the quality of life.

This study intends to use prospective clinical studies to further confirm the efficacy and safety of the anti-angiogenic drug rh-ES combined with traditional CV regimens in the treatment of children with LGGs.

Conditions: Low-grade Glioma, Pediatric Brain Tumor
Being tested: combined therapy with rh-ES and CV

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

combined therapy with rh-ES and CVDrug
All the patients receive combined therapy with recombinant human endostatin and traditional weekly CV regimen.
Carboplatin is administered at a dose of 220 mg/m2. Vincristine is administered at a dose of 1.5 mg/m2 (maximum dose 2 mg). Recombinant human endostatin (rh-ES) is administrated at a dose of 15mg daily, for 14 consecutive days every 3 weeks.

Study groups in NCT04659421
Study group	Role	What they receive
Low-grade gliomas	Experimental	Treated with Recombinant human endostatin, Carboplatin, and Vincristine Receives: Drug: combined therapy with rh-ES and CV

What is being measured

The primary outcome is the main question the study is designed to answer.

objective response rate
the percentage of patients who achieved confirmed complete response or partial response according to the Response Assessment in Neuro-Oncology (RANO) criteria
Measured: up to 5years

Secondary outcomes (5)

median time to response
Time interval from the beginning of chemotherapy to achieving CR, PR or MR
Measured: up to 5years
Progression-free survival
the time interval from treatment initiation to disease progression or death, whichever occurs first.
Measured: up to 5years
Overall survival
the time interval from treatment initiation to death from any cause.
Measured: up to 5years
The correlation between KPS change and efficacy
the correlation between KPS baseline, KPS change (increase, decrease,stable) and best efficacy (CR, PR, SD, PD).
Measured: up to 5years
Frequency and severity of treatment-related adverse events as assessed by CTCAE v5.0
Frequency and severity of treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: up to 5years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Nov 202020 Jul 2023

First posted9 Dec 2020
Study start3 Nov 2020
Primary completion1 Jul 2023
Study completion20 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Low-grade 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: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04659421
Sponsor's protocol ID: SBNK-YJ-2020-016-02
Status last verified: Jul 2023
First submitted: 24 Nov 2020
Last updated: 24 Jul 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingPhase 3
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
Low Grade Astrocytoma, Low Grade Glioma
RecruitingPhase 2
Dabrafenib and Trametinib for BRAF V600 Mutant Low-Grade Gliomas
BRAF V600 Mutation, Low-grade Glioma
Active, not recruitingPhase 2
Nivolumab in Patients With IDH-Mutant Gliomas With and Without Hypermutator Phenotype
Glioma, Glioblastoma
Active, not recruitingPhase 3
DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)
Low-grade Glioma, Rapidly Accelerated Fibrosarcoma (RAF) Altered Glioma

All Low-grade Glioma trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Singal-arm Clinical Study of Recombinant Human Endostatin (ENDOSTAR) Combined With Carboplatin and Vincristine in the Treatment of Low-grade Gliomas in Children
ClinicalTrials.gov ID: NCT04659421
Acronym / sponsor ID: SBNK-YJ-2020-016-02
Conditions: Low-grade Glioma, Pediatric Brain Tumor
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Beijing Sanbo Brain HospitalUniversity, hospital or other
Study start: 3 Nov 2020 (actual)
Primary completion: 1 Jul 2023 (actual)
Study completion: 20 Jul 2023 (actual)
First posted: 9 Dec 2020 (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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Low-grade gliomas	Experimental	Drug: combined therapy with rh-ES and CVTreated with Recombinant human endostatin, Carboplatin, and Vincristine

Who may qualify

Ages: 3 months to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (12 listed)

Age ≥ 3months and ≤18years;
Histopathologically confirmed low-grade glioma (WHO grade I and II), including astrocytoma, pilocytic astrocytoma, pleomorphic xanthoastrocytoma, subependymal giant cell astrocytoma, infantile desmoplastic astrocytoma, low-grade oligodendroglioma, oligoastrocytoma, ganglioglioma, and infantile desmoplastic ganglioglioma. Chiasmatic-hypothalamic tumors intrinsic to the optic pathway were eligible without pathologic confirmation.
There is a clear evaluable lesion with less than 95% resection or residual tumor of more than 1.5 cm^2；
KPS score ≥50 (age> 12 years old) or Lansky score ≥ 50 (age ≤ 12 years old)；
Estimated survival of at least 12 weeks;

Key exclusion criteria (13 listed)

MRI examination is not available;
Diffuse intrinsic pontine glioma or diffuse midline glioma with H3K27 mutation, even though the histopathology is grade I/II;
Non-glial low-grade rare intracranial tumors;
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
combined therapy with rh-ES and CVAll the patients receive combined therapy with recombinant human endostatin and traditional weekly CV regimen. Carboplatin is administered at a dose of 220 mg/m2. Vincristine is administered at a dose of 1.5 mg/m2 (maximum dose 2 mg). Recombinant human endostatin (rh-ES) is administrated at a dose of 15mg daily, for 14 consecutive days every 3 weeks.	Drug	Low-grade gliomas

Primary outcome

objective response rate
Time frame: up to 5years
the percentage of patients who achieved confirmed complete response or partial response according to the Response Assessment in Neuro-Oncology (RANO) criteria

5 secondary outcomes

median time to response
Time frame: up to 5years
Progression-free survival
Time frame: up to 5years
Overall survival
Time frame: up to 5years
The correlation between KPS change and efficacy
Time frame: up to 5years
Frequency and severity of treatment-related adverse events as assessed by CTCAE v5.0
Time frame: up to 5years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.

Related trials for Low-grade Glioma

Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingPhase 3
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
Low Grade Astrocytoma, Low Grade Glioma
RecruitingPhase 2
Dabrafenib and Trametinib for BRAF V600 Mutant Low-Grade Gliomas
BRAF V600 Mutation, Low-grade Glioma
Active, not recruitingPhase 2
Nivolumab in Patients With IDH-Mutant Gliomas With and Without Hypermutator Phenotype
Glioma, Glioblastoma
Active, not recruitingPhase 3
DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)
Low-grade Glioma, Rapidly Accelerated Fibrosarcoma (RAF) Altered Glioma

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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

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 combined therapy with rh-ES and CV in people with Low-grade Glioma and Pediatric Brain Tumor, 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 12 inclusion and 13 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: finished, as of the sponsor's last update on 24 Jul 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

objective response rate (time frame: up to 5years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04659421.

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 24 Jul 2023.