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Nimotuzumab Plus Radiotherapy With Concomitant and Adjuvant Temozolomide for Cerebral Glioblastoma

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ClinicalTrials.gov Identifier: NCT03388372
Recruitment Status : Completed
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Collaborator:
Sun Yat-sen University
Information provided by (Responsible Party):
Shao Xiong Wu, Sun Yat-sen University

Brief Summary:
This study aimed to investigate the clinical benefit contribution and safety of nimotuzumab to the standard combined treatment for patients with newly diagnosed glioblastoma.

Condition or disease Intervention/treatment Phase
Glioblastoma Biological: Nimotuzumab Drug: Temozolomide Radiation: Radiotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Nimotuzumab in Addition to Radiotherapy and Temozolomide for Cerebral Glioblastoma
Actual Study Start Date : August 18, 2010
Actual Primary Completion Date : March 23, 2017
Actual Study Completion Date : March 23, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nimotuzumab plus RT and temozolomide.
Nimotuzumab, administered once a week intravenously in addition to radiotherapy with concomitant and adjuvant temozolomide (TMZ) after surgery.
Biological: Nimotuzumab
Nimotuzumab, 200 mg as 1-hour intravenous infusion once weekly, from first week to last week of RT for a total of 6 times.

Drug: Temozolomide
Temozolomide, 75 mg/m2/d was administered orally from the first to the last day of RT. After 4-week break, individualized adjuvant TMZ was given based on MGMT status. The standard 5-day schedule every 4 weeks for six cycles was given for patients with negative MGMT expression. Dose was 150mg/m2 for the first cycle and 200 mg/m2 from the second cycle. The 7-day on/7-day off schedule every 2 weeks for 12 cycles was given for patients with positive MGMT expression. The dose was 100 mg/m2 for the first two cycles and 150 mg/m2 starting from the third cycle.

Radiation: Radiotherapy
Fractionated 3D conformal RT was given at 2.0Gy per fraction, 5 daily fractions per week for 6 weeks.




Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: 2 years ]
    PFS will be calculated as the time from surgery to the date of progression-free.

  2. Overall survival (OS) [ Time Frame: 2 years ]
    OS will be calculated as the time from surgery to the date of death.


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: 6 months ]
    ORR: overall response rate (ORR), subjects will be classified according to the RANO criteria, which is a composite of MRI changes, clinical response and changes in steroid use.

  2. Incidence of adverse events [ Time Frame: 6 months ]
    Incidence of adverse events.Toxicities will be tabulated and graded according to the NCI Common Toxicity Criteria (CTCAE) version 3.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed, histologically proven single supratentorial GBM (WHO grade 4);
  • EGFR positive;
  • >50% of the gross tumor volume removed by surgery;
  • Karnofsky performance score (KPS) ≥ 60;
  • Adequate renal function (creatinine ≤1.5×upper limit of normal [ULN] or creatinine clearance ≥ 60 mL/min), hepatic function (total bilirubin ≤1.5×ULN and serum transaminases ≤3×ULN), and hematologic function (white blood cell count ≥ 3,000/uL or absolute neutrophil count ≥ 1,500/uL, platelets ≥ 100,000/uL, and hemoglobin ≥ 10 g/dL).
  • Tumor tissue was required for central pathology review and re-checking EGFR and MGMT expression status;
  • An interval of 2 to 6 weeks between surgery and RT was required.

Exclusion Criteria:

  • Negative EGFR expression;
  • Prior chemotherapy, anti-EGFR therapy, RT, or a history of malignancy in the previous 5 years;
  • Patients with severe complications or active infection;
  • Continuous vomiting that could interfere with the oral administration of TMZ;
  • Pregnancy

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): NCT03388372


Locations
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China, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
China
Guangdong Brain Hospital
Guangdong, China
The First Affiliated Hospital/School of Clinical Medicine of Guangdong
Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
Shenzhen People's Hospital
Shenzhen, China
Sponsors and Collaborators
Biotech Pharmaceutical Co., Ltd.
Sun Yat-sen University
Investigators
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Principal Investigator: Shao-Xiong Wu, Professor Sun Yat-sen University

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Responsible Party: Shao Xiong Wu, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03388372     History of Changes
Other Study ID Numbers: NimotuzumabGBM2010
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Shao Xiong Wu, Sun Yat-sen University:
glioma
phase 2
nimotozumab
temozolomide
radiotherapy
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Nimotuzumab
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological