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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01337544
Other study ID # HNJ-NK-01/2009
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received March 25, 2011
Last updated November 8, 2013
Start date January 2011
Est. completion date November 2012

Study information

Verified date November 2013
Source Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Contact n/a
Is FDA regulated No
Health authority Spain: Spanish Agency of Medicines
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 6
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Both
Age group 6 Months to 22 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
HAPLOIDENTICAL IL-15 STIMULATED NK CELLS
ONE MEGADOSE 30 DAYS AFTER TRANSPLANTATION (DOSE WILL DEPEND ON PATIENT BODY WEIGHT)

Locations

Country Name City State
Spain Hospital Infantil Universitario Niño Jesus Madrid

Sponsors (2)

Lead Sponsor Collaborator
Hospital Infantil Universitario Niño Jesús, Madrid, Spain SPANISH HEALTH RESEARCH FUND (FIS)

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Pérez-Martínez A, Leung W, Muñoz E, Iyengar R, Ramírez M, Vicario JL, Lassaletta A, Sevilla J, González-Vicent M, Madero L, Díaz-Pérez MA. KIR-HLA receptor-ligand mismatch associated with a graft-versus-tumor effect in haploidentical stem cell transplantation for pediatric metastatic solid tumors. Pediatr Blood Cancer. 2009 Jul;53(1):120-4. doi: 10.1002/pbc.21955. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients with adverse events according to NCI-CTC v3.0 CRITERIA as a measure of safety and tolerability Up To 1 Year After Transplantation Yes
Secondary Objective Response Rate According RECIST V1.1 Up To One Year After Transplantation No
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