Oxaliplatin for Children With Solid Tumors
|ClinicalTrials.gov Identifier: NCT01558453|
Recruitment Status : Unknown
Verified March 2013 by Sidnei Epelman, Hospital Santa Marcelina.
Recruitment status was: Active, not recruiting
First Posted : March 20, 2012
Last Update Posted : March 26, 2013
|Condition or disease||Intervention/treatment||Phase|
|Relapsed Solid Tumor Refractory Solid Tumor||Drug: Oxaliplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study With Oxaliplatin In Children With Relapsed/Refractory Solid Tumors|
|Study Start Date :||March 2011|
|Estimated Primary Completion Date :||June 2013|
|Estimated Study Completion Date :||December 2013|
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).
- Determine pediatric neoplastic response to proposed chemotherapy. Evaluate sensitivity to oxaliplatin through immunohistochemistry ERCC-1 expression analysis. [ Time Frame: Up 2 years ]
- Define cumulative toxicity after oxaliplatin multiple cycles in this population. Evaluate relation between time exposure to the drug (number of cycles) and response (antitumor effect x response). [ Time Frame: Up 2 years ]Determine response time and overall survival in these patients.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01558453
|Santa Marcelina Hospital|
|Sao Paulo, SP, Brazil, 08270070|
|Study Chair:||Sidnei Epelman, MD||Santa Marcelina Hospital|