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Completed

NCT Number: NCT03388372

Nimotuzumab Plus Radiotherapy With Concomitant and Adjuvant Temozolomide for Cerebral Glioblastoma

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nimotuzumab

Biological

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

Temozolomide

Drug

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.

Radiotherapy

Radiation

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

Primary outcomes

  1. Progression-free survival (PFS)

    Time frame: 2 years

    PFS will be calculated as the time from surgery to the date of progression-free.

  2. Overall survival (OS)

    Time frame: 2 years

    OS will be calculated as the time from surgery to the date of death.

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: 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.

  2. Incidence of adverse events

    Time frame: 6 months

    Incidence of adverse events.Toxicities will be tabulated and graded according to the NCI Common Toxicity Criteria (CTCAE) version 3.

Sponsors and collaborators

Lead sponsor

Biotech Pharmaceutical Co., Ltd.

Other

Collaborators

  • Sun Yat-sen University

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Jan 3, 2018
Registry last updated
Jan 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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