Childhood Brain Stem Neoplasm
Conditions
Keywords
Radiation Therapy, Brainstem Tumor in Children
Brief 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.
Detailed 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.
Interventions
DRUGNimotuzumab
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.
DRUGTemozolomide
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).
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| Objective response rate (ORR) | first analysis will occur 1 month after accrual of all patients |
Countries
China
Contacts
Primary Contactchuanying zhu, MD
Outcome results
None listed