Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nimotuzumab in Combination With Radio-chemotherapy for the Treatment of Brainstem Tumor in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02672241
Recruitment Status : Recruiting
First Posted : February 3, 2016
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Chuanying Zhu, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of nimotuzumab in combination of radio-chemotherapy for the treatment of brainstem tumor in children.

Condition or disease Intervention/treatment Phase
Childhood Brain Stem Neoplasm Drug: Nimotuzumab Drug: Temozolomide Phase 2

Detailed Description:
Nimotuzumab (h-R3), a recombinant humanized monoclonal immunoglobulin G1 antibody that binds to the extracellular domain of EGFR, which blocks the binding of EGF and transforming growth factor-α to EGFR. High expression of EGFR protein in glioma has been associated with tumor progression and enhanced tumorigenicity. Several clinical trials have demonstrated the anti-tumor effects of nimotuzumab, such as head and neck cancer and esophageal cancer15. The purpose of this study was to evaluate the efficacy of nimotuzumab in combination of radio-chemotherapy for the treatment of brainstem tumors in children.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Nimotuzumab in Combination With Radio-chemotherapy for the Treatment of Brainstem Tumor in Children
Study Start Date : January 2016
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: radio-chemotherapy plus nimotuzumab
Radiotherapy: The total radiation dose is 52.2Gy (1.8Gy fractions). Chemotherapy: Nimotuzumab, given during radiotherapy, is administered via intravenous drip with a dosage of 150mg/m2, weekly, for 6 consecutive weeks. After radiotherapy and evaluation, disease progression-free patients will continue to receive Nimotuzumab treatment biweekly until disease relapse or progression. Temozolomide is applied to these patients as a chemotherapy drug with a dosage of 75mg/m2, daily. The chemotherapy and radiation therapy are combined as temozolomide is taken 1 hour prior to every fraction of radiotherapy. In 4 weeks after the completion of radiotherapy, temozolomide is given for 8 cycles.
Drug: Nimotuzumab
Nimotuzumab given during radiotherapy, is administered via intravenous drip with a dosage of 150mg/m2, weekly, for 6 consecutive weeks. After radiotherapy and evaluation, disease progression-free patients will continue to receive Nimotuzumab treatment biweekly until disease relapse or progression.
Other Name: h-R3, BIOMAb EGFR, Biocon

Drug: Temozolomide
Temozolomide is applied to these patients as a chemotherapy drug with a dosage of 75mg/m2, daily. The chemotherapy and radiation are combined as temozolomide is taken 1 hour prior to every fraction of radiotherapy. In 4 weeks after the completion of radiotherapy, temozolomide is given for 8 cycles (dosage: the 1st cycle, 150mg/m2, daily × 5 days, 4 weeks a cycle; the 2-8th cycle, 200mg/m2, daily × 5 days, 4 weeks a cycle and repeated again).
Other Name: brand names Temodar and Temodal and Temcad




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: first analysis will occur 1 month after accrual of all patients ]

Secondary Outcome Measures :
  1. Progression free survival(PFS) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months ]
  2. Overall survival (OS) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months ]
  3. Objective response rate (ORR) [ Time Frame: first analysis will occur 1 month after accrual of all patients ]


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.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be >/= 3 and </= 21 years of age.
  • Patients must have a newly diagnosed or progressive brain stem tumor.
  • If biopsy has been performed, patients with both high and low grade astrocytomas are eligible.
  • Non-histologically confirmed brain stem tumors are eligible. Neuroradiographic confirmation of brain stem glioma is mandatory for study entry.
  • Cervicomedullary junction tumors are ineligible.
  • Patients with a diagnosis of NF-1 are ineligible.
  • Patients must be registered within 6 weeks from diagnosis or recurrence.
  • Patients must have life expectancy > 6 weeks.
  • Patients must have adequate hematologic and renal function: ANC >1,000/ul, platelets>100,000/ul and creatinine normal for age: </= 0.7 mg/dl (age 3-10yrs.), </= 1.0 mg/dl (11-12yrs.). and </= 1.2 (13-21yrs.).
  • Written informed consent must be obtained according to institutional guidelines.

Exclusion Criteria:

  • Cervicomedullary junction tumors are ineligible.
  • Patients with a diagnosis of NF-1 are ineligible.
  • Pregnant or nursing women are ineligible.
  • Patients must not start treatment until informed consent is given and the patient is registered.

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): NCT02672241


Contacts
Layout table for location contacts
Contact: chuanying zhu, MD 862125076994 sdnanhai123@163.com

Locations
Layout table for location information
China, Shanghai
he Department of Radiation Oncology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200092
Contact: chuanying zhu, MD    862125076994    sdnanhai123@163.com   
Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
Layout table for investigator information
Principal Investigator: mawei jiang, MD The Department of Radiation Oncology, Xin Hua Hospital affiliated to Shanghai Jiaotong University School of Medicine

Layout table for additonal information
Responsible Party: Chuanying Zhu, doctor, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02672241     History of Changes
Other Study ID Numbers: sanghaixinhua-002
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Chuanying Zhu, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine:
Radiation Therapy
Brainstem Tumor in Children
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Stem Neoplasms
Infratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Temozolomide
Nimotuzumab
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological