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

July 24, 2023 updated by: Biotech Pharmaceutical Co., Ltd.

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Xuanwu Hospital Capital Medical University
        • Contact:
      • Beijing, China
        • Not yet recruiting
        • Peking Union Medical College Hospital
        • Contact:
      • Beijing, China
        • Recruiting
        • Beijing Tiantan Hospital, Capital Medical University
        • Contact:
      • Jinan, China
        • Not yet recruiting
        • Shandong Cancer Hospital
        • Contact:
      • Shanghai, China
        • Recruiting
        • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
        • Contact:
          • Xiaojun Yuan
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • The Third People's Hospital of Zhengzhou
        • Contact:
    • Hunan
      • Changsha, Hunan, China
        • Not yet recruiting
        • Xiangya Hospital of Centre-South University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China
        • Not yet recruiting
        • West China Hospital, Sichuan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 15 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

Other Names:
  • h-R3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate #ORR# assessed by the Independent Review Committee
Time Frame: Up to 12 months
Proportion of patients with partial or complete response in tumor burden as defined by RECIST.
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 12 months
Progression-free survival#PFS#
Time Frame: Up to 12 months
PFS is defined as the time from enrollment to disease progression or death from any cause.
Up to 12 months
Incidence of adverse events
Time Frame: Up to 30 days after last administration of Nimotuzumab
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotech Pharmaceutical Co., Ltd.

Investigators

  • Study Chair: Xiaojun Yuan, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
  • Study Chair: Xiaoguang Qiu, Beijing Tiantan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2021

Primary Completion (Estimated)

October 8, 2023

Study Completion (Estimated)

December 8, 2023

Study Registration Dates

First Submitted

August 26, 2020

First Submitted That Met QC Criteria

August 26, 2020

First Posted (Actual)

August 31, 2020

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 24, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BPL-Nim-DIPG-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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