CLINICAL TRIAL SUMMARY

MDACC Study No:2006-0374 (clinicaltrials.gov NCT No: NCT00539500)
Title:Autologous Stem Cell Rescue with CD133+ Selected Hematopoietic Progenitor Cells in Patients with High-risk Neuroblastoma
Principal Investigator:Laura L. Worth
Treatment Agent:Carboplatin; CD133; Etoposide; Filgrastim; Melphalan
Study Status:Terminated
Study Description: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.

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Disease Group:Blood And Marrow Transplantation; Pediatrics; Solid Tumors
Phase of Study:Phase II/Phase III
Treatment Agents:Carboplatin
CD133
Etoposide
Filgrastim
Melphalan
Treatment Location:Only at MDACC
Estimated Length of Stay in Houston:Treatment length is approximately 12 weeks from time of cell collection as an
outpatient to completion of high dose chemotherapy, cell infusion, and
engraftment.
Supported By:N/A
Return Visit:Post discharge patients come 1-2 x/ week for about 60 days post infusion.
Yearly followup assess for disease recurrence includes CT scan of original
tumor site &/or metastatic disease, CBC, diff, plt, electrolytes & chem survey;
history & phys. exam
Home Care:GCSF


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Physician Name:Laura L. Worth
Dept:Pediatrics
For Clinical Trial Enrollment:713-792-6620
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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