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Nimotuzumab in Combined With Concurrent Radiochemotherapy in the Treatment of Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) in Children

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ClinicalTrials.gov Identifier: NCT04532229
Recruitment Status : Recruiting
First Posted : August 31, 2020
Last Update Posted : April 22, 2021
Sponsor:
Information provided by (Responsible Party):
Biotech Pharmaceutical Co., Ltd.

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).

Condition or disease Intervention/treatment Phase
Diffuse Intrinsic Pontine Glioma Drug: Nimotuzumab+CRT(concurrent IMRT and TMZ) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 3, 2021
Estimated Primary Completion Date : October 8, 2022
Estimated Study Completion Date : December 8, 2022


Arm Intervention/treatment
Experimental: Experimental
Nimotuzumab+CRT(concurrent IMRT and TMZ)
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





Primary Outcome Measures :
  1. Objective response rate #ORR# [ Time Frame: Up to 12 months ]
    Proportion of patients with partial or complete response in tumor burden as defined by RECIST.


Secondary Outcome Measures :
  1. 1-year overall survival [ Time Frame: Up to 12 months ]
    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.

  2. Progression-free survival#PFS# [ Time Frame: Up to 12 months ]
  3. Incidence of adverse events [ Time Frame: Up to 30 days after last administration of Nimotuzumab ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04532229


Contacts
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Contact: Xiaojun Yuan 13817266192 13651718916@163.com
Contact: Xiaoguang Qiu 13701009917 ttyy6611@126.com

Locations
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China, Henan
The Third People's Hospital of Zhengzhou Recruiting
Zhengzhou, Henan, China
Contact: Gang Wang    18037791710    z214023wanggang@126.com   
China, Hunan
Xiangya Hospital of Centre-south University Not yet recruiting
Changsha, Hunan, China
Contact: Liangfang Shen    13975805137    slf1688@sina.com   
China, Sichuan
West China Hospital, Sichuan University Not yet recruiting
Chengdu, Sichuan, China
Contact: Qing Mao    18980601506    qingmao2000@163.com   
China
Beijing Tiantan Hospital, Capital Medical University Recruiting
Beijing, China
Contact: Xiaoguang Qiu    13701009917    ttyy6611@126.com   
Peking Union Medical College Hospital Not yet recruiting
Beijing, China
Contact: Wenbin Ma    13701364566    MAWB2001@hotmail.com   
Xuanwu Hospital Capital Medical University Recruiting
Beijing, China
Contact: Qingtang Lin    15801588169    kingsang2002@hotmail.com   
Shandong Cancer Hospital Not yet recruiting
Jinan, China
Contact: Rongjie Tao    13969191909    053113969191909@163.com   
Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine Recruiting
Shanghai, China
Contact: Xiaojun Yuan         
Sponsors and Collaborators
Biotech Pharmaceutical Co., Ltd.
Investigators
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Study Chair: Xiaojun Yuan Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study Chair: Xiaoguang Qiu Beijing Tiantan Hospital
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Responsible Party: Biotech Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT04532229    
Other Study ID Numbers: BPL-Nim-DIPG-1
First Posted: August 31, 2020    Key Record Dates
Last Update Posted: April 22, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biotech Pharmaceutical Co., Ltd.:
Nimotuzumab
Temozolomide
DIPG
Additional relevant MeSH terms:
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Glioma
Diffuse Intrinsic Pontine 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
Nimotuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents