Clinical Trial: Nimotuzumab in Combination With Radio-chemotherapy for the Treatment of Brainstem Tumor in Children
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Phase 2 Study of Nimotuzumab in Combination With Radio-chemotherapy for the Treatment of 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 Summary: 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.
Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Current Primary Outcome: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: first analysis will occur 1 month after accrual of all patients ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Progression free survival(PFS) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: first analysis will occur 1 month after accrual of all patients ]
Original Secondary Outcome: Same as current
Information By: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Dates:
Date Received: January 31, 2016
Date Started: January 2016
Date Completion: August 2017
Last Updated: September 11, 2016
Last Verified: September 2016