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Trials / Terminated

TerminatedNCT03420963

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

Ex-Vivo Expanded Allogeneic NK Cells for the Treatment of Solid Tumors of Pediatric Origin in Children and Young Adults

Status
Terminated
Phase
Phase 1
Study type
Interventional
Enrollment
12 (actual)
Sponsor
M.D. Anderson Cancer Center · Academic / Other
Sex
All
Age
12 Months – 40 Years
Healthy volunteers
Not accepted

Summary

This phase I trial studies the side effects and best dose of cord blood-derived expanded allogeneic natural killer cells (donor natural killer \[NK\] cells) and how well they work when given together with cyclophosphamide and etoposide in treating children and young adults with solid tumors that have come back (relapsed) or that do not respond to treatment (refractory). NK cells, white blood cells important to the immune system, are donated/collected from cord blood collected at birth from healthy babies and grown in the lab. Drugs used in chemotherapy, such as cyclophosphamide and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving NK cells together with cyclophosphamide and etoposide may work better in treating children and young adults with solid tumors.

Detailed description

PRIMARY OBJECTIVE: I. Determine the safety, maximum tolerated dose and/or recommended phase II dose of cord blood-derived expanded allogeneic natural killer cells (expanded allogeneic cord donor natural killer \[NK\] cells) following chemotherapy. SECONDARY OBJECTIVES: I. Determine the persistence of adoptively-transferred cord NK cells after solid tumor directed chemotherapy. II. Preliminarily define the antitumor activity to adoptively transferred NK cells following the study preparative regimen in the confines of a phase I study. III. Determine the immunophenotype and function of the infused NK cell product. IV. Preliminarily evaluate for any correlate of phenotype, killer cell immunoglobulin-like receptor (kir) haplotype, and function with overall response. OUTLINE: This is a dose escalation study of cord blood derived allogeneic NK cells. Patients receive cyclophosphamide intravenously (IV) once daily (QD) over 30 minutes and etoposide IV QD over 60 minutes on days 1-5 in the absence of unacceptable toxicity. Patients then receive cord blood derived allogeneic NK cells IV on day 8. After completion of study treatment, patients are followed up at 3-4 days, and then every week for 30 days.

Conditions

Interventions

TypeNameDescription
BIOLOGICALCord Blood-derived Expanded Allogeneic Natural Killer CellsGiven IV
DRUGCyclophosphamideGiven IV
DRUGEtoposideGiven IV

Timeline

Start date
2018-08-31
Primary completion
2026-02-26
Completion
2026-02-26
First posted
2018-02-05
Last updated
2026-03-20

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03420963. Inclusion in this directory is not an endorsement.

Donor Natural Killer Cells, Cyclophosphamide, and Etoposide in Treating Children and Young Adults With Relapsed or Refra (NCT03420963) · Clinical Trials Directory