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

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ClinicalTrials.gov Identifier: NCT00698009
Recruitment Status : Terminated (Slow accrual.)
First Posted : June 16, 2008
Results First Posted : November 22, 2012
Last Update Posted : November 22, 2012
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Neuroblastoma
Interventions Drug: Fludarabine
Drug: Cyclophosphamide
Biological: Natural Killer Cell Infusion
Drug: Mesna
Drug: Interleukin-2
Enrollment 1
Recruitment Details Recruitment period June 05, 2008 to December 03, 2010. All recruitment done at UT MD Anderson Cancer Center.
Pre-assignment Details  
Arm/Group Title Fludarabine + Cyclophosphamide + NK Cell Infusion
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 1
Completed 0
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Fludarabine + Cyclophosphamide + NK Cell Infusion
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants
10
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
1.Primary Outcome
Title Participant Disease Response
Hide Description Neuroblastoma International Response Criteria: Complete Response (CR): No evidence of disease (primary and metastasis) clinically & radiographic studies, (homovanillic acid (HVA)/vanillylmandelic acid (VMA) normal). Very Good Partial Response (VGPR): >90% reduction in primary tumor, resolution all metastatic tumor except bone. No new bone lesions and improvement on scan of all pre-existing lesions; HVA/VMA decreased >90%. Partial Response (PR): 50-90% reduction primary and all measurable metastatic lesions, 0-1 bone marrow samples with tumor; scans of bone lesions same as VGPR. HVA/VMA decreased 50-90%. Mixed Response (MR): > 50% reduction any measurable disease (primary or metastases); no new lesions; <25% increase in any existing lesion (exclude bone marrow evaluation). No Response (NR): No new lesions; < 25% increase in existing lesion. Progressive Disease (PD): Any new lesions. Increase <25% in measurable lesion, previous negative bone marrow positive for tumor.
Time Frame 1 Year for overall patient response, or until disease progression
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fludarabine + Cyclophosphamide + NK Cell Infusion
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Number of Participants Infused Haploidentical Donor-derived Natural Killer (NK) Cells and Low-dose Interleukin-2 (IL-2)
Hide Description Feasibility of an infused allogeneic donor NK cell product and IL-2 following a cyclophosphamide and fludarabine preparative regimen to treat relapsed neuroblastoma after autologous peripheral blood stem cell (PBSC) transplant where feasibility is defined as being able to infuse NK cells on day 0.
Time Frame 21 days, up to 1 year
Outcome Measure Data Not Reported
Time Frame 4 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fludarabine + Cyclophosphamide + NK Cell Infusion
Hide Arm/Group Description 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.
All-Cause Mortality
Fludarabine + Cyclophosphamide + NK Cell Infusion
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fludarabine + Cyclophosphamide + NK Cell Infusion
Affected / at Risk (%) # Events
Total   0/1 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fludarabine + Cyclophosphamide + NK Cell Infusion
Affected / at Risk (%) # Events
Total   1/1 (100.00%)    
Immune system disorders   
Fever - Neutropenia  1  1/1 (100.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Laurence Cooper, Professor
Organization: UT MD Anderson Cancer Center
EMail: rnjackso@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00698009     History of Changes
Other Study ID Numbers: 2006-0752
First Submitted: June 12, 2008
First Posted: June 16, 2008
Results First Submitted: October 23, 2012
Results First Posted: November 22, 2012
Last Update Posted: November 22, 2012