Back to resultsNimotuzumab Plus Radiotherapy With Concomitant and Adjuvant Temozolomide for Cerebral Glioblastoma
Primary Purpose
Glioblastoma
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Nimotuzumab
Temozolomide
Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Glioblastoma focused on measuring glioma, phase 2, nimotozumab, temozolomide, radiotherapy
Eligibility 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
Sites / Locations
- Sun Yat-sen University Cancer Center
- Guangdong Brain Hospital
- The First Affiliated Hospital/School of Clinical Medicine of Guangdong
- The First Affiliated Hospital of Guangzhou Medical University
- Shenzhen People's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nimotuzumab plus RT and temozolomide.
Arm Description
Nimotuzumab, administered once a week intravenously in addition to radiotherapy with concomitant and adjuvant temozolomide (TMZ) after surgery.
Outcomes
Primary Outcome Measures
Progression-free survival (PFS)
PFS will be calculated as the time from surgery to the date of progression-free.
Overall survival (OS)
OS will be calculated as the time from surgery to the date of death.
Secondary Outcome Measures
Objective Response Rate (ORR)
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
Incidence of adverse events.Toxicities will be tabulated and graded according to the NCI Common Toxicity Criteria (CTCAE) version 3.
Full Information
NCT ID
NCT03388372
First Posted
December 11, 2017
Last Updated
December 24, 2017
Sponsor
Biotech Pharmaceutical Co., Ltd.
Collaborators
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT03388372
Brief Title
Nimotuzumab Plus Radiotherapy With Concomitant and Adjuvant Temozolomide for Cerebral Glioblastoma
Official Title
Efficacy and Safety of Nimotuzumab in Addition to Radiotherapy and Temozolomide for Cerebral Glioblastoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
August 18, 2010 (Actual)
Primary Completion Date
March 23, 2017 (Actual)
Study Completion Date
March 23, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Biotech Pharmaceutical Co., Ltd.
Collaborators
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma
Keywords
glioma, phase 2, nimotozumab, temozolomide, radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nimotuzumab plus RT and temozolomide.
Arm Type
Experimental
Arm Description
Nimotuzumab, administered once a week intravenously in addition to radiotherapy with concomitant and adjuvant temozolomide (TMZ) after surgery.
Intervention Type
Biological
Intervention Name(s)
Nimotuzumab
Intervention Description
Nimotuzumab, 200 mg as 1-hour intravenous infusion once weekly, from first week to last week of RT for a total of 6 times.
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
Fractionated 3D conformal RT was given at 2.0Gy per fraction, 5 daily fractions per week for 6 weeks.
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
PFS will be calculated as the time from surgery to the date of progression-free.
Time Frame
2 years
Title
Overall survival (OS)
Description
OS will be calculated as the time from surgery to the date of death.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
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.
Time Frame
6 months
Title
Incidence of adverse events
Description
Incidence of adverse events.Toxicities will be tabulated and graded according to the NCI Common Toxicity Criteria (CTCAE) version 3.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shao-Xiong Wu, Professor
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Guangdong Brain Hospital
City
Guangdong
Country
China
Facility Name
The First Affiliated Hospital/School of Clinical Medicine of Guangdong
City
Guangdong
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
Country
China
Facility Name
Shenzhen People's Hospital
City
Shenzhen
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Nimotuzumab Plus Radiotherapy With Concomitant and Adjuvant Temozolomide for Cerebral Glioblastoma
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