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Nimotuzumab Plus Radiotherapy With Concomitant and Adjuvant Temozolomide for Cerebral Glioblastoma

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. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE December 11, 2017
First Posted Date  ICMJE January 3, 2018
Last Update Posted Date January 3, 2018
Actual Study Start Date  ICMJE August 18, 2010
Actual Primary Completion Date March 23, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 24, 2017)
  • Progression-free survival (PFS) [ Time Frame: 2 years ]
    PFS will be calculated as the time from surgery to the date of progression-free.
  • Overall survival (OS) [ Time Frame: 2 years ]
    OS will be calculated as the time from surgery to the date of death.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 24, 2017)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nimotuzumab Plus Radiotherapy With Concomitant and Adjuvant Temozolomide for Cerebral Glioblastoma
Official Title  ICMJE Efficacy and Safety of Nimotuzumab in Addition to Radiotherapy and Temozolomide for Cerebral Glioblastoma
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Experimental: Nimotuzumab plus RT and temozolomide.
Nimotuzumab, administered once a week intravenously in addition to radiotherapy with concomitant and adjuvant temozolomide (TMZ) after surgery.
Interventions:
  • Biological: Nimotuzumab
  • Drug: Temozolomide
  • Radiation: Radiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 24, 2017)
39
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 23, 2017
Actual Primary Completion Date March 23, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03388372
Other Study ID Numbers  ICMJE NimotuzumabGBM2010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Shao Xiong Wu, Sun Yat-sen University
Study Sponsor  ICMJE Biotech Pharmaceutical Co., Ltd.
Collaborators  ICMJE Sun Yat-sen University
Investigators  ICMJE
Principal Investigator: Shao-Xiong Wu, Professor Sun Yat-sen University
PRS Account Biotech Pharmaceutical Co., Ltd.
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP