Topotecan, Ifosfamide and Carboplatin in Children and Young Adults With Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00502892|
Recruitment Status : Completed
First Posted : July 18, 2007
Last Update Posted : August 1, 2012
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors||Drug: Topotecan Drug: Ifosfamide Drug: Carboplatin||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of a Novel Chemotherapeutic Regimen: Topotecan, Ifosfamide and Carboplatin (TIC) in Children and Young Adults With Solid Tumors-- A Limited Multi-Institution Study|
|Study Start Date :||August 2004|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
|Experimental: Topotecan + Ifosfamide + Carboplatin||
0.5 mg/m^2 IV Daily x 3 Days
Other Name: Hycamtin
1.8 grams/m^2 IV Over 1 Hour x 5 Days
Other Name: Ifex
AUC = 3 mg/ml/min IV Over 1 Hour x 3 Days [for patients > 22 yrs of age, 3 mg/mL/min IV Over 1 Hour x 2 Days]
Other Name: Paraplatin
- Maximum tolerated dose (MTD) [ Time Frame: Blood tests on Days 1, 3, 5, then twice weekly and on Day 22 of each course; Urine tests done on Day 1 of each course and at end of Course 2. ]
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): NCT00502892
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Robert J. Wells, MD||M.D. Anderson Cancer Center|