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

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 2

Conditions: Childhood Brain Stem Neoplasm

Treatments: Drug: Temozolomide; Drug: Nimotuzumab

Study type: Interventional

Funder types: Other

Identifiers

NCT02672241

sanghaixinhua-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

radio-chemotherapy plus nimotuzumab

Experimental group

Description:

Radiotherapy: The total radiation dose is 52.2Gy (1.8Gy fractions). Chemotherapy: 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 is applied to these patients as a chemotherapy drug with a dosage of 75mg/m2, daily. The chemotherapy and radiation therapy 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.

Treatment:

Drug: Nimotuzumab

Drug: Temozolomide