drugset / Trial / NCT00502892

Topotecan, Ifosfamide and Carboplatin in Children and Young Adults With Solid Tumors

NCT00502892

Phase 1 Completed 2 enrolled M.D. Anderson Cancer Center
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2004-08
Primary completion
2010-01
Completion
2010-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Topotecan Small molecule 0.5 mg/m2 Intravenous
Background Carboplatin Small molecule 3 unknown Intravenous
Background Ifosfamide Small molecule 1800 mg/m2 Intravenous

Indications