Feasibility of Thioridazine as a Mobilizing Agent for CD34+ Hematopoietic Progenitor Cells

This study has been terminated.
(Primary objective not met after planned interim analysis)
Sponsor:
Collaborator:
Oxnard Foundation
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT01765803
First received: January 8, 2013
Last updated: June 19, 2015
Last verified: June 2015
Results First Received: June 19, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Healthy Subjects
Intervention: Drug: Mellaril

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Mellaril (Thioridazine)

A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study

Mellaril: 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.


Participant Flow:   Overall Study
    Mellaril (Thioridazine)  
STARTED     6  
COMPLETED     6  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Mellaril (Thioridazine)

A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study

Mellaril: 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.


Baseline Measures
    Mellaril (Thioridazine)  
Number of Participants  
[units: participants]
  6  
Age  
[units: years]
Median (Full Range)
  34   (24 to 43)  
Gender  
[units: participants]
 
Female     4  
Male     2  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   CD34+ Progenitor Cell Mobilization   [ Time Frame: 24 hours following treatment ]

2.  Secondary:   Toxicity   [ Time Frame: Up to 1 month after treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Stuart Winter, MD
Organization: University of New Mexico
phone: 505-272-4461
e-mail: SWinter@salud.unm.edu


No publications provided


Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT01765803     History of Changes
Other Study ID Numbers: INST 1208
Study First Received: January 8, 2013
Results First Received: June 19, 2015
Last Updated: June 19, 2015
Health Authority: United States: Food and Drug Administration