Feasibility of Thioridazine as a Mobilizing Agent for CD34+ Hematopoietic Progenitor Cells
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|ClinicalTrials.gov Identifier: NCT01765803|
Recruitment Status : Terminated (Primary objective not met after planned interim analysis)
First Posted : January 10, 2013
Results First Posted : July 20, 2015
Last Update Posted : April 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|Healthy Subjects||Drug: Mellaril||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Institution Feasibility Study to Assess Thioridazine as a Mobilizing Agent for CD34+ Hematopoietic Progenitor Cells|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||December 2013|
Experimental: Mellaril (thioridazine)
A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study
Subjects will undergo a physical exam including an electrocardiogram (EKG) and have blood drawn before treatment. A single 50 gm dose of thioridazine (Mellaril) will be given to eligible subjects. A second blood draw will occur at 24 hours post-treatment.
Other Name: Thioridazine
- CD34+ Progenitor Cell Mobilization [ Time Frame: 8 hours following treatment ]To measure CD34+ cells, a peripheral blood draw is taken from the enrolled subject at hour zero on day one of the study before treatment with oral thioridazine. Following treatment, blood draws are taken at 2, 4, 8 and 24 hours. These blood samples are analyzed using Clinical Laboratory Improvement Amendments (CLIA)-approved flow cytometry for CD34+ cell content. CD34+ cell levels will be reported as a percentage of total white blood cells (WBC) in the blood specimens and the difference between baseline and 8 hours will be reported
- Toxicity [ Time Frame: Up to 1 month after treatment ]
Toxicity will be evaluated according to the grading system (0-5) NCI CTCAE (Common Terminology Criteria for Adverse Events) version 4.
Any subject who receives treatment on this protocol will be evaluable for toxicity.
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): NCT01765803
|United States, New Mexico|
|University of New Mexico Health Sciences Center|
|Albuquerque, New Mexico, United States, 87131|
|Principal Investigator:||Stuart S Winter, MD||University of New Mexico Health Sciences Center/Pediatric Oncology|