This study will be with pediatric patients who have refractory/recurrent solid tumors. They will receive standard chemotherapy (ICE) and we are investigating if the addition of a new drug, ODSH, will help to increase the time of their platelet recovery after ICE chemotherapy.The purpose of this study is to evaluate the safety and tolerability of ODSH in pediatric patients receiving "ICE" chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
New York Medical College
Valhalla, New York, United States
To determine if ODSH is safe in pediatric patients
All patients will be followed for 60 days after the last dose of ODSH in a treatment cycle in which ODSH is administered. All serious adverse events related to ODSH will be monitored.
Time frame: 60 days following last dose of ODSH
To see if ODSH has a positive effect on platelet recovery
Platelet counts will be monitored to determine when the platelet count remained \> 100,000 after nadir for two consecutive days in the absence of a prior platelet transfusion within the previous 48 hours in pediatric patients receiving "ICE" chemotherapy.
Time frame: 60 days after last dose of ODSH
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