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

• Status: Unknown status
• Trial end date: 2019-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Treatments: Dacarbazine; Nimotuzumab; Temozolomide

Criteria

Inclusion Criteria:

• Patients must be >/= 3 and
• 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:1.0 mg/dl (11-12yrs.). and
• 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.