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

NCT04659421 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-07-24

No results posted yet for this study

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, and malignant transformation during their development. The prognosis of LGGs is related to the degree of tumor resection, histological type, and whether it has spread.

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

Interventions

DRUG

combined therapy with rh-ES and CV

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.

Sponsors & Collaborators

  • Beijing Sanbo Brain Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-03
Primary Completion
2023-07-01
Completion
2023-07-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04659421 on ClinicalTrials.gov