Nimotuzumab in Combined With Chemoradiotherapy to Treat the Newly Diagnosed Diffuse Intrinsic Pontine Glioma in Children

NCT04532229 | Unknown Phase 3 DMC

• 1 other identifier: BPL-Nim-DIPG-1
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 8

Brief Summary

This is a prospective, open-label, single arm, multicenter clinical study. The purpose of the study is to evaluate the clinical efficacy and safety of combination Nimotuzumab with concurrent radiochemotherapy in children with newly diagnosed diffuse intrinsic pontine glioma(DIPG).

Conditions

Diffuse Intrinsic Pontine Glioma

Keywords

Nimotuzumab; Temozolomide; DIPG

Outcome Measures

Primary Outcomes (1)

• Objective response rate #ORR# assessed by the Independent Review Committee

  Proportion of patients with partial or complete response in tumor burden as defined by RECIST.

  Up to 12 months

Secondary Outcomes (3)

• 1-year overall survival

  Up to 12 months

• Progression-free survival#PFS#

  Up to 12 months

• Incidence of adverse events

  Up to 30 days after last administration of Nimotuzumab

Study Arms (1)

Experimental

EXPERIMENTAL

Nimotuzumab+CRT(concurrent IMRT and TMZ)

Drug: Nimotuzumab+CRT(concurrent IMRT and TMZ)

Interventions

Nimotuzumab+CRT(concurrent IMRT and TMZ) DRUG

Drug: Nimotuzumab Concurrent radiochemotherapy period, 150mg/m2, weekly, for 6 weeks; Maintenance period, from the 7th to the 52nd week, 150mg/m2, every two weeks until disease progression or intolerable toxicity. Other Names: h-R3 Drug: Temozolomide Concurrent radiochemotherapy period, 75mg/m2, daily, for 6 weeks; Maintenance period, rest from the 7th to 10th weeks, from the 11th week, 150-200mg/m2, day1 to day5, 21 days for a cycle, for 6 cycles. Other Names: TMZ

Also known as: h-R3

Experimental

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Voluntary and sign a consent form;
• Age 3-15 years old, gender unlimited;
• Histology or imaging diagnosed as diffuse intrinsic pontine glioma, patients haven't received any anti-tumor treatment;
• According to the RANO criteria, at least one measurable lesion;
• Before enrollment, the results of laboratory examination are in accordance with:
• Blood routine test: platelet count ≥ 100 × 10\^9/L; absolute neutrophil count ≥ 1.5 × 10\^9/L or leukocyte count ≥ 3.0 × 10\^9/L; hemoglobin ≥ 90g/L; Blood biochemistry: aspartate aminotransferase#AST# ≤ 3 ×Upper Limit Of Normal#ULN#; alanine aminotransferase#ALT# ≤ 3 × ULN; total bilirubin ≤ 1.5 × ULN; serum creatinine ≤ 1.5 × ULN;
• Lansky score ≥ 60;
• Expected survival time ≥ 3 months;
• Fertile subjects are willing to take contraceptive measures during the study period.

You may not qualify if:

• Recurrent DIPG;
• Have received any other anti-tumor treatment for DIPG, including surgical treatment (except biopsy), chemotherapy, radiotherapy, targeted drugs, immunotherapy, etc;
• Uncontrollable infection, epilepsy and / or hypertension and / or hyperglycemia;
• Human immunodeficiency virus #HIV# infection or active hepatitis B infection or hepatitis C infection;
• Have other malignant tumor history;
• Known allergy to Nimotuzumab, temozolomide or its analogues or any component of the prescription;
• Unable to tolerate radiotherapy;
• Other reasons that are not suitable to participate in this study according to the researcher's judgment.

Sponsors & Collaborators

• Biotech Pharmaceutical Co., Ltd.: lead

Study Sites (8)

The Third People's Hospital of Zhengzhou

Zhengzhou, Henan, China

RECRUITING

Xiangya Hospital of Centre-south University

Changsha, Hunan, China

NOT YET RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, China

NOT YET RECRUITING

Beijing Tiantan Hospital, Capital Medical University

Beijing, China

RECRUITING

Peking Union Medical College Hospital

Beijing, China

NOT YET RECRUITING

Xuanwu Hospital Capital Medical University

Beijing, China

RECRUITING

Shandong Cancer Hospital

Jinan, China

NOT YET RECRUITING

Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Diffuse Intrinsic Pontine Glioma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Brain Stem Neoplasms; Infratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Xiaojun Yuan

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  STUDY CHAIR

• Xiaoguang Qiu

  Beijing Tiantan Hospital

  STUDY CHAIR

Central Study Contacts

Xiaojun Yuan

CONTACT

13817266192; 13651718916@163.com

Xiaoguang Qiu

CONTACT

13701009917; ttyy6611@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: August 31, 2020
• Study Start: April 3, 2021
• Primary Completion: October 8, 2023
• Study Completion: December 8, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)