Oxaliplatin for Children With Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|