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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| radio-chemotherapy plus nimotuzumab | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nimotuzumab | Drug | 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. |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| chuanying zhu, MD | Contact | 862125076994 | sdnanhai123@163.com |
| Name | Affiliation | Role |
|---|---|---|
| mawei jiang, MD | The Department of Radiation Oncology, Xin Hua Hospital affiliated to Shanghai Jiaotong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| he Department of Radiation Oncology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200092 | China |
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| ID | Term |
|---|---|
| C501466 | nimotuzumab |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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| Temozolomide | Drug | 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). |
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| Objective response rate (ORR) | first analysis will occur 1 month after accrual of all patients |
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| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |