Nimotuzumab Plus Radiotherapy With Concomitant and Adjuvant Temozolomide for Cerebral Glioblastoma

NCT03388372 | Completed Phase 2

• 1 other identifier: NimotuzumabGBM2010
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 5

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.

Conditions

Glioblastoma

Keywords

glioma; phase 2; nimotozumab; temozolomide; radiotherapy

Outcome Measures

Primary Outcomes (2)

• Progression-free survival (PFS)

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

  2 years

• Overall survival (OS)

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

  2 years

Secondary Outcomes (2)

• Objective Response Rate (ORR)

  6 months

• Incidence of adverse events

  6 months

Study Arms (1)

Nimotuzumab plus RT and temozolomide.

EXPERIMENTAL

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

Biological: Nimotuzumab; Drug: Temozolomide; Radiation: Radiotherapy

Interventions

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.

Nimotuzumab plus RT and temozolomide.

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.

Nimotuzumab plus RT and temozolomide.

Radiotherapy RADIATION

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

Nimotuzumab plus RT and temozolomide.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotech Pharmaceutical Co., Ltd.: lead
• Sun Yat-sen University: collaborator

Study Sites (5)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Guangdong Brain Hospital

Guangdong, China

Location

The First Affiliated Hospital/School of Clinical Medicine of Guangdong

Guangdong, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Location

Shenzhen People's Hospital

Shenzhen, China

Location

MeSH Terms

Conditions

Glioblastoma; Glioma

Interventions

nimotuzumab; Temozolomide; Radiotherapy

Condition Hierarchy (Ancestors)

Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Shao-Xiong Wu, Professor

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: January 3, 2018
• Study Start: August 18, 2010
• Primary Completion: March 23, 2017
• Study Completion: March 23, 2017
• Last Updated: January 3, 2018

Record last verified: 2017-12

Locations

CN (5)