NCT01558453

Oxaliplatin for Children With Solid Tumors

Phase II Study With Oxaliplatin In Children With Relapsed/Refractory Solid Tumors

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Sidnei Epelman · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the pediatric neoplastic response to chemotherapy proposed and evaluate sensitivity to oxaliplatin through immunohistochemistry ERCC-1 expression analysis.

Conditions

• Relapsed Solid Tumor
• Refractory Solid Tumor

Interventions

Type	Name	Description
DRUG	Oxaliplatin	Oxaliplatin will be administered in a 130 mg/m² dose, 2 hour IV infusion, once every 3 weeks. Each cycle will last 3 weeks, or 21 days. Drug will be administered till progression disease or untolerable adverse event. NOTE: patients with ≤ 12 months old will receive a 4,3 mg/kg dese (based on a 30 kg/m² conversion; i.e: in a 130 mg/m² dose, divided by 30).

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-06-01
• Completion: 2013-12-01
• First posted: 2012-03-20
• Last updated: 2013-03-26

Locations

1 site across 1 country: Brazil