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Haploidentical Stem Cell Transplantation and IL-15 NK Cell Infusion for Paediatric Refractory Solid Tumours (NK)

This study has been terminated.
(The parents of two patients enrolled who died, presented a claim against the hospital and the study was halted.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01337544
First Posted: April 19, 2011
Last Update Posted: November 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
SPANISH HEALTH RESEARCH FUND (FIS)
Information provided by (Responsible Party):
Antonio Perez-Martinez, Hospital Infantil Universitario Niño Jesús, Madrid, Spain
  Purpose

The investigators propose a new antitumor cell therapy for treating childhood refractory solid tumours. The aim of this study is explore the graft versus tumour effect mediated by allogenic natural killer cells (NKs). NK cell alloreactivity can be predicted by donor killer immunoglobulin-like receptors (KIRs) and human leukocyte antigen (HLA) class I alleles mismatch. Cells without an inhibitory HLA ligand may trigger natural killer cell activation and elimination of those target cells. Reduced risk of relapsed has been described in malignant cancer after haploidentical stem cell transplantation when HLA ligands against the inhibitory KIRs present in the donor were absent in the recipient (KIR-HLA receptor-ligand mismatch). NK alloreactivity could also be obtained by Natural Killer Receptor (NCR), Toll-Like-Receptors (TLRs) and NKG2D receptor stimulation mediated by cytokines or tumour cell lines.

This will be an open, non randomized, Phase I/II clinical trial, with a double objective: therapeutic exploratory. The investigators aim at studying safety and efficacy of haploidentical stem cell transplantation for the treatment of these malignancies with no cure known. Patients will receive an haploidentical stem cell transplantation, followed by IL-15 stimulated NK cells infusion one month after transplantation. Efficacy of the procedure will be evaluated with up-to-date radiological techniques, molecular studies and functional assays.


Condition Intervention Phase
Childhood Solid Tumor Other: HAPLOIDENTICAL IL-15 STIMULATED NK CELLS Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Haploidentical Stem Cell Transplantation and IL-15 NK Cell Infusion for Paediatric Refractory Solid Tumours

Further study details as provided by Antonio Perez-Martinez, Hospital Infantil Universitario Niño Jesús, Madrid, Spain:

Primary Outcome Measures:
  • Number of patients with adverse events according to NCI-CTC v3.0 CRITERIA as a measure of safety and tolerability [ Time Frame: Up To 1 Year After Transplantation ]

Secondary Outcome Measures:
  • Objective Response Rate According RECIST V1.1 [ Time Frame: Up To One Year After Transplantation ]

Enrollment: 6
Study Start Date: January 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IL-15 STIMULATED NK CELLS Other: HAPLOIDENTICAL IL-15 STIMULATED NK CELLS
ONE MEGADOSE 30 DAYS AFTER TRANSPLANTATION (DOSE WILL DEPEND ON PATIENT BODY WEIGHT)
Other Name: CELL THERAPY

Detailed Description:
The investigators propose a new antitumor cell therapy for treating childhood refractory solid tumours. The aim of this study is explore the graft versus tumour effect mediated by allogenic natural killer cells (NKs). NK cell alloreactivity can be predicted by donor killer immunoglobulin-like receptors (KIRs) and human leukocyte antigen (HLA) class I alleles mismatch. Cells without an inhibitory HLA ligand may trigger natural killer cell activation and elimination of those target cells. Reduced risk of relapsed has been described in malignant cancer after haploidentical stem cell transplantation when HLA ligands against the inhibitory KIRs present in the donor were absent in the recipient (KIR-HLA receptor-ligand mismatch). NK alloreactivity could also be obtained by Natural Killer Receptor (NCR), Toll-Like-Receptors (TLRs) and NKG2D receptor stimulation mediated by cytokines or tumour cell lines.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 6 months to 22 years.
  • Histological solid tumor confirmation.
  • Measurable solid tumor by image or molecular techniques.
  • Solid tumors that have failed to at least 2 chemotherapy protocols.
  • Suitable haploidentical donor available.
  • Lansky score > 60%.

Exclusion Criteria:

  • Serum bilirubin > 3 mg/dl
  • GFR < 40 ml/min/1.73 mw
  • Cardiac left ventricular ejection fraction < 40%
  • HIV+
  • Pregnant
  • Unfavorable psycho-social report.
  • Antecedent of abandonment treatment.
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01337544


Locations
Spain
Hospital Infantil Universitario Niño Jesus
Madrid, Spain, 28009
Sponsors and Collaborators
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
SPANISH HEALTH RESEARCH FUND (FIS)
Investigators
Principal Investigator: ANTONIO PEREZ-MARTINEZ, MD, PhD HOSPITAL UNIVERSITARIO NINO JESUS
  More Information

Additional Information:
Publications:
Responsible Party: Antonio Perez-Martinez, Servicio de Hemato-Oncología Pediátrica, Hospital Infantil Universitario Niño Jesús, Madrid, Spain
ClinicalTrials.gov Identifier: NCT01337544     History of Changes
Other Study ID Numbers: HNJ-NK-01/2009
First Submitted: March 25, 2011
First Posted: April 19, 2011
Last Update Posted: November 11, 2013
Last Verified: November 2013

Keywords provided by Antonio Perez-Martinez, Hospital Infantil Universitario Niño Jesús, Madrid, Spain:
HAPLOIDENTICAL STEM CELL TRANSPLANTATION
NK CELL
IL-15