Nimotuzumab Plus Radiotherapy With Concomitant and Adjuvant Temozolomide for Cerebral Glioblastoma

• ClinicalTrials.gov Identifier: NCT03388372
• Recruitment Status: Completed
• First Posted: January 3, 2018
• Last Update Posted: January 3, 2018
• Sponsor: Biotech Pharmaceutical Co., Ltd.
• Collaborator: Sun Yat-sen University
• Information provided by (Responsible Party): Shao Xiong Wu, Sun Yat-sen University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Glioblastoma	Biological: Nimotuzumab; Drug: Temozolomide; Radiation: Radiotherapy	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 39 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Nimotuzumab in Addition to Radiotherapy and Temozolomide for Cerebral Glioblastoma
• Actual Study Start Date: August 18, 2010
• Actual Primary Completion Date: March 23, 2017
• Actual Study Completion Date: March 23, 2017

Arms and Interventions

Arm

Intervention/treatment

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

Biological: 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.; Drug: 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.; Radiation: Radiotherapy; Fractionated 3D conformal RT was given at 2.0Gy per fraction, 5 daily fractions per week for 6 weeks.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

China, Guangdong

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510060

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

Sponsors and Collaborators

Biotech Pharmaceutical Co., Ltd.

Sun Yat-sen University

Investigators

• Principal Investigator: Shao-Xiong Wu, Professor; Sun Yat-sen University

More Information

• Responsible Party: Shao Xiong Wu, Professor, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT03388372 History of Changes
• Other Study ID Numbers: NimotuzumabGBM2010
• First Posted: January 3, 2018
• Last Update Posted: January 3, 2018
• Last Verified: December 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by Shao Xiong Wu, Sun Yat-sen University:

glioma; phase 2; nimotozumab; temozolomide; radiotherapy

Additional relevant MeSH terms:

Glioblastoma; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Temozolomide; Nimotuzumab; Antineoplastic Agents, Alkylating; Alkylating Agents; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological