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 after 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 after cyclophosphamide and etoposide may make them work better in treating children and young adults with solid tumors.
Additional locations may be listed on ClinicalTrials.gov for NCT03420963.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Demetrios Petropoulos
Phone: 713-792-3746
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. Patients then receive cord blood derived allogeneic NK cells IV on day 8 in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed up at 3-4 days, and then every week for 30 days.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorDemetrios Petropoulos