Topotecan, Ifosfamide and Carboplatin in Children and Young Adults With Solid Tumors
Status:
Completed
Trial end date:
2010-01-01
Target enrollment:
Participant gender:
Summary
Primary Objectives:
- To determine the maximum tolerated dose (MTD) of Topotecan when added to a fixed dose
regimen of Ifosfamide and Carboplatin in children and young adults with solid tumors.
- To evaluate the toxicity associated with the administration of Topotecan with Ifosfamide
and Carboplatin (TIC) in children and young adults with solid tumors.
Secondary Objectives:
- To evaluate the duration of neutropenia (ANC<500/micro L) and thrombocytopenia (PLT
50,000/ micro L and 20,000/ micro L) and the number of days of platelet transfusion
during each course of TIC chemotherapy when used in conjunction with G-CSF and NEUMEGA
in children and young adults with solid tumors.
- To determine the median number of apheresis collections as well as the CD34/kg, CD41/kg,
CD61/kg and CD34:41/kg and CD34:61/kg per collection in patients electively undergoing
concurrent apheresis for peripheral blood stem cell collection in courses 2 or 3.
- To determine the median number of peripheral blood mononuclear cells (PBMC) and ex-vivo
expanded myeloid dendritic cells (DC) in patients electively undergoing concurrent
apheresis for PBMC collection in courses 2 or 3.