Autologous Stem Cell Rescue With CD133+ Selected Cells in High-Risk Neuroblastoma
NCT00539500 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 3
Last updated 2019-07-26
Summary
The goal of this clinical research study is to learn how long it takes for certain types of transplanted stem cells to produce new blood cells. The safety of this treatment will also be studied. Finally, researchers want to learn if collecting the cells with the CliniMACS device can decrease the possibility of tumor cells contaminating (appearing in) the stem cells that are reinfused into participants.
Conditions
Interventions
- DRUG
-
Carboplatin by vein over 24 hours for 4 days, dosing as determined at day 1.
- DRUG
-
Etoposide
300 mg/m\^2 by vein over 24 hours for 4 days
- DRUG
-
Melphalan
70 mg/m\^2 Intravenous Bolus for 3 Days
- PROCEDURE
-
Stem Cell Infusion
Stem Cell Infusion (approximately 5x10\^8 TNC cells/kg CD133+ selected) on Day 0.
- DEVICE
-
ClinicMACS
Device used to process the blood and separate the CD 133+ cells needed for transplantation
Sponsors & Collaborators
-
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Laura L. Worth, MD, PhD · M.D. Anderson Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-10-31
- Primary Completion
- 2012-09-05
- Completion
- 2012-09-05
Countries
- United States
Study Locations
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