Nimotuzumab Plus Radiotherapy With Concomitant and Adjuvant Temozolomide for Cerebral Glioblastoma

Phase 2

Completed

• Conditions: Glioblastoma
• Interventions: Biological: Nimotuzumab; Drug: Temozolomide; Radiation: Radiotherapy

• Registration Number: NCT03388372
• Lead Sponsor: Biotech Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-18
• Primary Completion: 2017-03-23
• Study Completion: 2017-03-23
• Status Verified: 2017-12
• Study First Submitted: 2017-12-11
• Study First Submitted QC: 2017-12-24
• Last Update Submitted: 2017-12-24
• Study First Posted: 2018-01-03
• Last Update Posted: 2018-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nimotuzumab plus RT and temozolomide.	Nimotuzumab	Nimotuzumab, administered once a week intravenously in addition to radiotherapy with concomitant and adjuvant temozolomide (TMZ) after surgery.
Nimotuzumab plus RT and temozolomide.	Radiotherapy	Nimotuzumab, administered once a week intravenously in addition to radiotherapy with concomitant and adjuvant temozolomide (TMZ) after surgery.
Nimotuzumab plus RT and temozolomide.	Temozolomide	Nimotuzumab, administered once a week intravenously in addition to radiotherapy with concomitant and adjuvant temozolomide (TMZ) after surgery.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (5)

The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, China

Guangdong Brain Hospital; 🇨🇳 Guangdong, China

Shenzhen People's Hospital; 🇨🇳 Shenzhen, China

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China

The First Affiliated Hospital/School of Clinical Medicine of Guangdong; 🇨🇳 Guangdong, China