Clinical trial NCT04532229: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diffuse Intrinsic Pontine Glioma
Keywords: Nimotuzumab
Temozolomide
DIPG
Lead sponsor: Biotech Pharmaceutical Co., Ltd.
Sponsor class: OTHER
First posted: 2020-08-31
Enrollment: 48
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Objective response rate #ORR# assessed by the Independent Review Committee
timeFrame: Up to 12 months
Secondary outcomes:
measure: 1-year overall survival
timeFrame: Up to 12 months
measure: Progression-free survival#PFS#
timeFrame: Up to 12 months
measure: Incidence of adverse events
timeFrame: Up to 30 days after last administration of Nimotuzumab
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The Third People's Hospital of Zhengzhou
state: Henan
city: Changsha
country: China
facility: Xiangya Hospital of Centre-south University
state: Hunan
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
city: Jinan
country: China
facility: Shandong Cancer Hospital
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Xiaojun Yuan
role: STUDY_CHAIR
affiliation: Beijing Tiantan Hospital
name: Xiaoguang Qiu
role: STUDY_CHAIR
References: