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

Diffuse Intrinsic Pontine Glioma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04532229
• Other study ID #: BPL-Nim-DIPG-1
• Status: Recruiting
• Phase: Phase 3
• Start date: April 3, 2021
• Est. completion date: December 8, 2023

Study information

• Verified date: February 2023
• Source: Biotech Pharmaceutical Co., Ltd.
• Contact: Xiaojun Yuan
• Phone: 13817266192
• Email: 13651718916[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 8, 2023
• Est. primary completion date: October 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diffuse Intrinsic Pontine Glioma
• Glioma

Intervention

Drug:
• Nimotuzumab+CRT(concurrent IMRT and TMZ)
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

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing
China	Peking Union Medical College Hospital	Beijing
China	Xuanwu Hospital Capital Medical University	Beijing
China	Xiangya Hospital of Centre-south University	Changsha	Hunan
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	Shandong Cancer Hospital	Jinan
China	Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine	Shanghai
China	The Third People's Hospital of Zhengzhou	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Biotech Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Up to 12 months
Secondary	Progression-free survival#PFS#	PFS is defined as the time from enrollment to disease progression or death from any cause.	Up to 12 months
Secondary	Incidence of adverse events	An adverse event is any adverse event that occurs in a patient or subject of a drug clinical study.	Up to 30 days after last administration of Nimotuzumab