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Nimotuzumab Plus Radiotherapy With Concomitant and Adjuvant Temozolomide for Cerebral Glioblastoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT03388372•Biotech Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

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

Locations (5)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Guangdong Brain Hospital

Guangdong, China

The First Affiliated Hospital/School of Clinical Medicine of Guangdong

Guangdong, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Shenzhen People's Hospital

Shenzhen, China

Key Dates

Start Date

August 18, 2010

Primary Completion Date

March 23, 2017

Completion Date

March 23, 2017

Last Updated

January 3, 2018

Enrollment

ACTUAL participants

Conditions

Glioblastoma

Interventions

Nimotuzumab

BIOLOGICAL

Temozolomide

DRUG

Radiotherapy

RADIATION

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

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Glioblastoma Multiforme

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RECRUITINGPHASE1

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

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Astrocytoma, IDH-Mutant, Grade 2Recurrent Adult Diffuse Hemispheric Glioma, H3 G34-Mutant+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 3, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Nimotuzumab Plus Radiotherapy With Concomitant and Adjuvant Temozolomide for Cerebral Glioblastoma

Inclusion Criteria

Exclusion Criteria

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

Targeted Pediatric High-Grade Glioma Therapy

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EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma

Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma