Nimotuzumab Plus Radiotherapy With Concomitant and Adjuvant Temozolomide for Cerebral Glioblastoma

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03388372

Enrollment

Registered

2018-01-03

Start date

2010-08-18

Completion date

2017-03-23

Last updated

2018-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma

Keywords

glioma, phase 2, nimotozumab, temozolomide, radiotherapy

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.

Interventions

BIOLOGICALNimotuzumab

Nimotuzumab, 200 mg as 1-hour intravenous infusion once weekly, from first week to last week of RT for a total of 6 times.

DRUGTemozolomide

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.

RADIATIONRadiotherapy

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Progression-free survival (PFS)	2 years	PFS will be calculated as the time from surgery to the date of progression-free.
Overall survival (OS)	2 years	OS will be calculated as the time from surgery to the date of death.

Secondary

Measure	Time frame	Description
Objective Response Rate (ORR)	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	6 months	Incidence of adverse events.Toxicities will be tabulated and graded according to the NCI Common Toxicity Criteria (CTCAE) version 3.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026