Nimotuzumab Plus Radiotherapy With Concomitant and Adjuvant Temozolomide for Cerebral Glioblastoma

• Status: Completed
• Trial end date: 2017-03-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biotech Pharmaceutical Co., Ltd.
• Collaborator: Sun Yat-sen University
• Treatments: Nimotuzumab; Temozolomide

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