NCT01337544

Brief 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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2011

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 19, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

November 11, 2013

Status Verified

November 1, 2013

Enrollment Period

1.8 years

First QC Date

March 25, 2011

Last Update Submit

November 8, 2013

Conditions

Childhood Solid Tumor

Keywords

HAPLOIDENTICAL STEM CELL TRANSPLANTATIONNK CELLIL-15

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Objective Response Rate According RECIST V1.1

    Up To One Year After Transplantation

Study Arms (1)

IL-15 STIMULATED NK CELLS

EXPERIMENTAL
Other: HAPLOIDENTICAL IL-15 STIMULATED NK CELLS

Interventions

HAPLOIDENTICAL IL-15 STIMULATED NK CELLSOTHER

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

Also known as: CELL THERAPY
IL-15 STIMULATED NK CELLS

Eligibility Criteria

Age6 Months - 22 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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%.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Infantil Universitario Niño Jesus

Madrid, Madrid, 28009, Spain

Location

Related Publications (1)

  • 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.

    PMID: 19215002BACKGROUND

MeSH Terms

Interventions

Cell- and Tissue-Based Therapy

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • ANTONIO PEREZ-MARTINEZ, MD, PhD

    HOSPITAL UNIVERSITARIO NINO JESUS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Servicio de Hemato-Oncología Pediátrica

Study Record Dates

First Submitted

March 25, 2011

First Posted

April 19, 2011

Study Start

January 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

November 11, 2013

Record last verified: 2013-11

Locations

ES(1)