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

NCT ID: NCT01337544

Last Updated: 2013-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Childhood Solid Tumor

Keywords

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HAPLOIDENTICAL STEM CELL TRANSPLANTATION NK CELL IL-15

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IL-15 STIMULATED NK CELLS

Group Type EXPERIMENTAL

HAPLOIDENTICAL IL-15 STIMULATED NK CELLS

Intervention Type OTHER

ONE MEGADOSE 30 DAYS AFTER TRANSPLANTATION (DOSE WILL DEPEND ON PATIENT BODY WEIGHT)

Interventions

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HAPLOIDENTICAL IL-15 STIMULATED NK CELLS

ONE MEGADOSE 30 DAYS AFTER TRANSPLANTATION (DOSE WILL DEPEND ON PATIENT BODY WEIGHT)

Intervention Type OTHER

Other Intervention Names

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CELL THERAPY

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SPANISH HEALTH RESEARCH FUND (FIS)

UNKNOWN

Sponsor Role collaborator

Hospital Infantil Universitario Niño Jesús, Madrid, Spain

OTHER

Sponsor Role lead

Responsible Party

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Antonio Perez-Martinez

Servicio de Hemato-Oncología Pediátrica

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ANTONIO PEREZ-MARTINEZ, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

HOSPITAL UNIVERSITARIO NINO JESUS

Locations

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Hospital Infantil Universitario Niño Jesus

Madrid, Madrid, Spain

Site Status

Countries

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Spain

References

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Perez-Martinez A, Leung W, Munoz E, Iyengar R, Ramirez M, Vicario JL, Lassaletta A, Sevilla J, Gonzalez-Vicent M, Madero L, Diaz-Perez 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.

Reference Type BACKGROUND
PMID: 19215002 (View on PubMed)

Other Identifiers

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HNJ-NK-01/2009

Identifier Type: -

Identifier Source: org_study_id