Nimotuzumab Plus Radiotherapy With Concomitant and Adjuvant Temozolomide for Cerebral Glioblastoma

Glioblastoma Clinical Trial

Official title:

Efficacy and Safety of Nimotuzumab in Addition to Radiotherapy and Temozolomide for Cerebral Glioblastoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03388372
• Other study ID #: NimotuzumabGBM2010
• Status: Completed
• Phase: Phase 2
• First received: December 11, 2017
• Last updated: December 24, 2017
• Start date: August 18, 2010
• Est. completion date: March 23, 2017

Study information

• Verified date: December 2017
• Source: Biotech Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: March 23, 2017
• Est. primary completion date: March 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma

Intervention

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.

Locations

Country	Name	City	State
China	Guangdong Brain Hospital	Guangdong
China	The First Affiliated Hospital/School of Clinical Medicine of Guangdong	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou
China	Shenzhen People's Hospital	Shenzhen

Sponsors (2)

Lead Sponsor	Collaborator
Biotech Pharmaceutical Co., Ltd.	Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)	PFS will be calculated as the time from surgery to the date of progression-free.	2 years
Primary	Overall survival (OS)	OS will be calculated as the time from surgery to the date of death.	2 years
Secondary	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.	6 months
Secondary	Incidence of adverse events	Incidence of adverse events.Toxicities will be tabulated and graded according to the NCI Common Toxicity Criteria (CTCAE) version 3.	6 months