Nimotuzumab Plus Radiotherapy With Concomitant and Adjuvant Temozolomide for Cerebral Glioblastoma

Biotech Pharmaceutical

Status and phase

Completed

Phase 2

Conditions

Glioblastoma

Treatments

Radiation: Radiotherapy

Biological: Nimotuzumab

Drug: Temozolomide

Study type

Interventional

Funder types

Other

Identifiers

NCT03388372

NimotuzumabGBM2010

Details and patient eligibility

About

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

Enrollment

39 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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