Nimotuzumab in Combination With Radio-chemotherapy for the Treatment of Brainstem Tumor in Children

Childhood Brain Stem Neoplasm Clinical Trial

Official title:

Phase 2 Study of Nimotuzumab in Combination With Radio-chemotherapy for the Treatment of Brainstem Tumor in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02672241
• Other study ID #: sanghaixinhua-002
• Status: Recruiting
• Phase: Phase 2
• Start date: January 2016
• Est. completion date: August 2019

Study information

• Verified date: October 2018
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: chuanying zhu, MD
• Phone: 862125076994
• Email: sdnanhai123[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of nimotuzumab in combination of radio-chemotherapy for the treatment of brainstem tumor in children.

Description:

Nimotuzumab (h-R3), a recombinant humanized monoclonal immunoglobulin G1 antibody that binds to the extracellular domain of EGFR, which blocks the binding of EGF and transforming growth factor-α to EGFR. High expression of EGFR protein in glioma has been associated with tumor progression and enhanced tumorigenicity. Several clinical trials have demonstrated the anti-tumor effects of nimotuzumab, such as head and neck cancer and esophageal cancer15. The purpose of this study was to evaluate the efficacy of nimotuzumab in combination of radio-chemotherapy for the treatment of brainstem tumors in children.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

Inclusion Criteria:

• Patients must be >/= 3 and </= 21 years of age.

• Patients must have a newly diagnosed or progressive brain stem tumor.

• If biopsy has been performed, patients with both high and low grade astrocytomas are eligible.

• Non-histologically confirmed brain stem tumors are eligible. Neuroradiographic confirmation of brain stem glioma is mandatory for study entry.

• Cervicomedullary junction tumors are ineligible.

• Patients with a diagnosis of NF-1 are ineligible.

• Patients must be registered within 6 weeks from diagnosis or recurrence.

• Patients must have life expectancy > 6 weeks.

• Patients must have adequate hematologic and renal function: ANC >1,000/ul, platelets>100,000/ul and creatinine normal for age: </= 0.7 mg/dl (age 3-10yrs.), </= 1.0 mg/dl (11-12yrs.). and </= 1.2 (13-21yrs.).

• Written informed consent must be obtained according to institutional guidelines.

Exclusion Criteria:

• Cervicomedullary junction tumors are ineligible.

• Patients with a diagnosis of NF-1 are ineligible.

• Pregnant or nursing women are ineligible.

• Patients must not start treatment until informed consent is given and the patient is registered.

Related Conditions & MeSH terms

• Brain Stem Neoplasms
• Childhood Brain Stem Neoplasm

Intervention

Drug:
• Nimotuzumab
Nimotuzumab given during radiotherapy, is administered via intravenous drip with a dosage of 150mg/m2, weekly, for 6 consecutive weeks. After radiotherapy and evaluation, disease progression-free patients will continue to receive Nimotuzumab treatment biweekly until disease relapse or progression.
• Temozolomide
Temozolomide is applied to these patients as a chemotherapy drug with a dosage of 75mg/m2, daily. The chemotherapy and radiation are combined as temozolomide is taken 1 hour prior to every fraction of radiotherapy. In 4 weeks after the completion of radiotherapy, temozolomide is given for 8 cycles (dosage: the 1st cycle, 150mg/m2, daily × 5 days, 4 weeks a cycle; the 2-8th cycle, 200mg/m2, daily × 5 days, 4 weeks a cycle and repeated again).

Locations

Country	Name	City	State
China	he Department of Radiation Oncology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		first analysis will occur 1 month after accrual of all patients
Secondary	Progression free survival(PFS)		From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary	Overall survival (OS)		From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary	Objective response rate (ORR)		first analysis will occur 1 month after accrual of all patients