Know Cancer

or
forgot password

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


Phase 1/Phase 2
6 Months
22 Years
Open (Enrolling)
Both
Childhood Solid Tumor

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of patients with adverse events according to NCI-CTC v3.0 CRITERIA as a measure of safety and tolerability

Outcome Time Frame:

Up To 1 Year After Transplantation

Safety Issue:

Yes

Principal Investigator

ANTONIO PEREZ-MARTINEZ, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

HOSPITAL UNIVERSITARIO NINO JESUS

Authority:

Spain: Spanish Agency of Medicines

Study ID:

HNJ-NK-01/2009

NCT ID:

NCT01337544

Start Date:

January 2011

Completion Date:

January 2014

Related Keywords:

  • Childhood Solid Tumor
  • HAPLOIDENTICAL STEM CELL TRANSPLANTATION
  • NK CELL
  • IL-15
  • Neoplasms

Name

Location