Haploidentical Natural Killer (NK) Cells in Patients With Relapsed or Refractory Neuroblastoma
|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
Evaluate safety, feasibility, persistence, and anti-tumor effect of infused haploidentical donor-derived natural killer (NK) cells and low-dose interleukin-2 (IL-2).
- Quantification of cytokine levels;
- Assessment of NK cell immunophenotype and function.
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma||Drug: Fludarabine Drug: Cyclophosphamide Biological: Natural Killer Cell Infusion Drug: Mesna Drug: Interleukin-2||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study to Infuse Haploidentical Natural Killer Cells in Patients With Relapsed or Refractory Neuroblastoma|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
Experimental: 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.
25 mg/m^2 By Vein Daily Over 30 minutes Starting 6 days before the NK cell infusion (considered Day -6) and once a day through Day -2.
60 mg/kg By Vein Daily Over 2 Hours On Days -5 and -4
Biological: Natural Killer Cell Infusion
Natural Killer Cell Infusion on Day 0.
12 mg/kg By Vein, Over about 15 minutes, Five Times Per Day on Days -5 and -4.
Other Name: Mesnex
Received under skin three times weekly for 9 total doses following NK Cell Infusion:
For patients weighing 45 kg or more, dose administered is 10 Million units three times weekly for 9 total doses. For patients less than 45 kg, dose administered is 5 Million units/m2 (max dose 10 Million units) three times weekly for 9 total doses.
- Participant Disease Response [ Time Frame: 1 Year for overall patient response, or until disease progression ]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.
- 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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00698009
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Susan S. Kelly, MD||M.D. Anderson Cancer Center|