Nimotuzumab Plus Radiotherapy With Concomitant and Adjuvant Temozolomide for Cerebral Glioblastoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-18

Study Completion Date

2017-03-23

Brief Summary

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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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Detailed Description

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Conditions

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Glioblastoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nimotuzumab plus RT and temozolomide.

Nimotuzumab, administered once a week intravenously in addition to radiotherapy with concomitant and adjuvant temozolomide (TMZ) after surgery.

Group Type EXPERIMENTAL

Nimotuzumab

Intervention Type 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

Intervention Type 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

Intervention Type RADIATION

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

Interventions

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Nimotuzumab

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

Intervention Type BIOLOGICAL

Temozolomide

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.

Intervention Type DRUG

Radiotherapy

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

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No