Donor Natural Killer Cells, Cyclophosphamide, and Etoposide in Treating Children and Young Adults With Relapsed or Refractory Solid Tumors

Last Update Posted : 2022-09-26

The aim of this trial is to test the side effects and best dose of natural killer cells in combination with the chemotherapy drugs cyclophosphamide and etoposide. They are testing this in several types of cancer that has either returned or has not responded to treatment. People with osteosarcoma may be able to take part. Please contact your doctor or the trial team for more information.

Natural Killer cells (NKs) are cells that are part of the immune system. They recognise abnormal cells in the body and both directly kill and activate other immune cells to help kill them. An NK infusion involves putting NK cells into the body with the hope that they will help to kill cancer cells.
Visit our drugs and interventions page to find out more about this treatment, including how it works and what it’s used for.

The below points are a summary of who can enter the trial.
People who are older than 21 must have a solid tumor considered by study doctor to be of the childhood cancer type. The trial team will discuss this with you.
People who have had a sample of their tumour taken to confirm their cancer diagnosis.
People whose cancer has returned or hasn’t responded to any treatment for which no other treatments are available.
People whose cancer can be measured.
People who have sufficiently recovered from previous treatment.
People must have a performance status corresponding to a Karnofsky over 60% for participants > 16 years of age and Lansky over 60% for participants ≤ 16 years of age. Your doctor will know this.
People with adequate bone marrow, liver and kidney function. You will have tests to check this.
People with any lung symptoms mst have them controlled by medication and pulse oximetry >= 92% on room air. Your doctor will know this.
People of childbearing potential must follow the contraceptive guidelines in the study.
People must have confirmation that a cord blood donor which is matched with the recipient at a 4, 5, or 6/6 human leukocyte antigen (HLA) class I (serological) and HLA class II (molecular) antigens. Your doctor will know this.

The below points are a summary of who can’t enter the trial.
People with primary tumours of the central nervous system.
People who are taking high-dose steroids.
People with an uncontrolled irregular heartbeat or uncontrolled symptoms of heart disease.
People with uncontrolled infections.
People who are pregnant or breastfeeding.
People whose cancer has spread to the lungs, location or bulkiness of disease such that it may cause uncontrolled symptoms or oxygen dependence. Your doctor will know this.

ONTEX is intended to supplement, not replace, your healthcare team. Patients should always discuss a clinical trial with their healthcare team. If a patient is eligible for a trial the trial team will be able to provide more in-depth information about the trial so the patient can make an informed decision before taking part. Trial information has been sourced from www.clinicaltrials.gov. The content is then reviewed weekly by the Osteosarcoma Now team. All the trials also have a patient-friendly summary and key information section written by the team at Osteosarcoma Now. We have also included a description of the medications being used in the trial and summarised the inclusion and exclusion criteria in the ‘who is this trial (not) for’ sections. To the best of our knowledge the clinical trial database is up-to-date and accurate.However, we cannot assume any liability for the accuracy or completeness of the information.