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

Primary Purpose

Diffuse Intrinsic Pontine Glioma

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Nimotuzumab+CRT(concurrent IMRT and TMZ)
Sponsored by
Biotech Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Intrinsic Pontine Glioma focused on measuring Nimotuzumab, Temozolomide, DIPG

Eligibility Criteria

3 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Voluntary and sign a consent form;
  2. Age 3-15 years old, gender unlimited;
  3. Histology or imaging diagnosed as diffuse intrinsic pontine glioma, patients haven't received any anti-tumor treatment;
  4. According to the RANO criteria, at least one measurable lesion;

  5. 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;

  6. Lansky score ≥ 60;
  7. Expected survival time ≥ 3 months;
  8. Fertile subjects are willing to take contraceptive measures during the study period.

Exclusion Criteria:

  1. Recurrent DIPG;
  2. Have received any other anti-tumor treatment for DIPG, including surgical treatment (except biopsy), chemotherapy, radiotherapy, targeted drugs, immunotherapy, etc;
  3. Uncontrollable infection, epilepsy and / or hypertension and / or hyperglycemia;
  4. Human immunodeficiency virus #HIV# infection or active hepatitis B infection or hepatitis C infection;
  5. Active hemorrhage found by CT or MRI before inclusion and / or inability to carry out CT and MRI examination;
  6. Major operation (except biopsy) were performed within four weeks before inclusion;
  7. Decompensated heart failure (NYHA grades III and IV), unstable angina, acute myocardial infarction, persistent and clinically significant arrhythmia within three months of inclusion;
  8. Have other malignant tumor history;
  9. Known allergy to Nimotuzumab, temozolomide or its analogues or any component of the prescription;
  10. Unable to tolerate radiotherapy;
  11. Other reasons that are not suitable to participate in this study according to the researcher's judgment.

Sites / Locations

  • The Third People's Hospital of ZhengzhouRecruiting
  • Xiangya Hospital of Centre-south University
  • West China Hospital, Sichuan University
  • Beijing Tiantan Hospital, Capital Medical UniversityRecruiting
  • Peking Union Medical College Hospital
  • Xuanwu Hospital Capital Medical UniversityRecruiting
  • Shandong Cancer Hospital
  • Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

Nimotuzumab+CRT(concurrent IMRT and TMZ)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

1-year overall survival
The possibility that a patient who has lived for 1 year after treatment will still survive. OS is defined as the time from enrollment to death.
Progression-free survival#PFS#
PFS is defined as the time from enrollment to disease progression or death from any cause.
Incidence of adverse events
An adverse event is any adverse event that occurs in a patient or subject of a drug clinical study.

Full Information

First Posted
August 26, 2020
Last Updated
July 24, 2023
Sponsor
Biotech Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04532229
Brief Title
Nimotuzumab in Combined With Chemoradiotherapy to Treat the Newly Diagnosed Diffuse Intrinsic Pontine Glioma in Children
Official Title
A Multicenter, Prospective, Open and Single Arm Clinical Study of Nimotuzumab Combined With Concurrent Radiochemotherapy in the Treatment of Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) in Children
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 3, 2021 (Actual)
Primary Completion Date
October 8, 2023 (Anticipated)
Study Completion Date
December 8, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotech Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
Detailed Description
This clinical study is designed as a prospective, open-label, single arm, multicenter study to evaluate the clinical efficacy and safety of combination Nimotuzumab with concurrent radiochemotherapy in children with newly diagnosed diffuse intrinsic pontine glioma(DIPG). The main endpoint is objective response rate, 1-year overall survival rate is also observed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Intrinsic Pontine Glioma
Keywords
Nimotuzumab, Temozolomide, DIPG

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Nimotuzumab+CRT(concurrent IMRT and TMZ)
Intervention Type
Drug
Intervention Name(s)
Nimotuzumab+CRT(concurrent IMRT and TMZ)
Other Intervention Name(s)
h-R3
Intervention Description
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
Primary Outcome Measure Information:
Title
Objective response rate #ORR# assessed by the Independent Review Committee
Description
Proportion of patients with partial or complete response in tumor burden as defined by RECIST.
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
1-year overall survival
Description
The possibility that a patient who has lived for 1 year after treatment will still survive. OS is defined as the time from enrollment to death.
Time Frame
Up to 12 months
Title
Progression-free survival#PFS#
Description
PFS is defined as the time from enrollment to disease progression or death from any cause.
Time Frame
Up to 12 months
Title
Incidence of adverse events
Description
An adverse event is any adverse event that occurs in a patient or subject of a drug clinical study.
Time Frame
Up to 30 days after last administration of Nimotuzumab

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; Active hemorrhage found by CT or MRI before inclusion and / or inability to carry out CT and MRI examination; Major operation (except biopsy) were performed within four weeks before inclusion; Decompensated heart failure (NYHA grades III and IV), unstable angina, acute myocardial infarction, persistent and clinically significant arrhythmia within three months of inclusion; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaojun Yuan
Phone
13817266192
Email
13651718916@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoguang Qiu
Phone
13701009917
Email
ttyy6611@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaojun Yuan
Organizational Affiliation
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Xiaoguang Qiu
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
The Third People's Hospital of Zhengzhou
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gang Wang
Phone
18037791710
Email
z214023wanggang@126.com
Facility Name
Xiangya Hospital of Centre-south University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liangfang Shen
Phone
13975805137
Email
slf1688@sina.com
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qing Mao
Phone
18980601506
Email
qingmao2000@163.com
Facility Name
Beijing Tiantan Hospital, Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoguang Qiu
Phone
13701009917
Email
ttyy6611@126.com
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenbin Ma
Phone
13701364566
Email
MAWB2001@hotmail.com
Facility Name
Xuanwu Hospital Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingtang Lin
Phone
15801588169
Email
kingsang2002@hotmail.com
Facility Name
Shandong Cancer Hospital
City
Jinan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rongjie Tao
Phone
13969191909
Email
053113969191909@163.com
Facility Name
Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaojun Yuan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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