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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	3 Years - 15 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04532229
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Biotech Pharmaceutical Co., Ltd.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Xiaojun YuanXiaoguang Qiu
Principal Investigator Affiliation	Xinhua Hospital, Shanghai Jiao Tong University School of MedicineBeijing Tiantan Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Diffuse Intrinsic Pontine Glioma

Additional Details

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.

Arms & Interventions

Arms

Experimental: Experimental

Nimotuzumab+CRT(concurrent IMRT and TMZ)

Interventions

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

Contact a Trial Team

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