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Haploidentical Natural Killer (NK) Cells in Patients With Relapsed or Refractory Neuroblastoma

This study has been terminated.
(Slow accrual.)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00698009
First received: June 12, 2008
Last updated: October 23, 2012
Last verified: October 2012
Results First Received: October 23, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Neuroblastoma
Interventions: Drug: Fludarabine
Drug: Cyclophosphamide
Biological: Natural Killer Cell Infusion
Drug: Mesna
Drug: Interleukin-2

  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
Recruitment period June 05, 2008 to December 03, 2010. All recruitment done at UT MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Fludarabine + Cyclophosphamide + NK Cell Infusion Fludarabine 25 mg/m^2 intravenous (IV) Daily Over 30 minutes Starting 6 days before the NK cell infusion (considered Day -6) and once a day through Day -2. Cyclophosphamide 60 mg/kg IV Daily Over 2 Hours On Days -5 and -4. Natural Killer Cell Infusion on Day 0. Mesna 12 mg/kg By Vein, Over about 15 minutes, 5 Times Per Day on Days -5 and -4. Interleukin-2 subcutaneously three times weekly for 9 total doses following NK Cell Infusion.

Participant Flow:   Overall Study
    Fludarabine + Cyclophosphamide + NK Cell Infusion  
STARTED     1  
COMPLETED     0  
NOT COMPLETED     1  
Withdrawal by Subject                 1  



  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.
No text entered.

Reporting Groups
  Description
Fludarabine + Cyclophosphamide + NK Cell Infusion Fludarabine 25 mg/m^2 intravenous (IV) Daily Over 30 minutes Starting 6 days before the NK cell infusion (considered Day -6) and once a day through Day -2. Cyclophosphamide 60 mg/kg IV Daily Over 2 Hours On Days -5 and -4. Natural Killer Cell Infusion on Day 0. Mesna 12 mg/kg By Vein, Over about 15 minutes, 5 Times Per Day on Days -5 and -4. Interleukin-2 subcutaneously three times weekly for 9 total doses following NK Cell Infusion.

Baseline Measures
    Fludarabine + Cyclophosphamide + NK Cell Infusion  
Number of Participants  
[units: participants]
  1  
Age  
[units: years]
Median ± Standard Deviation
  10  
Gender  
[units: participants]
 
Female     0  
Male     1  
Region of Enrollment  
[units: participants]
 
United States     1  



  Outcome Measures

1.  Primary:   Participant Disease Response   [ Time Frame: 1 Year for overall patient response, or until disease progression ]

2.  Primary:   Number of Participants Infused Haploidentical Donor-derived Natural Killer (NK) Cells and Low-dose Interleukin-2 (IL-2)   [ Time Frame: 21 days, up to 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
No text entered.


  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: Dr. Laurence Cooper, Professor
Organization: UT MD Anderson Cancer Center
e-mail: rnjackso@mdanderson.org


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00698009     History of Changes
Other Study ID Numbers: 2006-0752
Study First Received: June 12, 2008
Results First Received: October 23, 2012
Last Updated: October 23, 2012
Health Authority: United States: Food and Drug Administration