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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • Bone Neoplasms
  • Endocrine Gland Neoplasms
  • Genital Neoplasms, Female
  • Genital Neoplasms, Male
  • Lung Neoplasms
  • Melanoma
  • Mesothelioma
  • Mesothelioma, Malignant
  • Mouth Neoplasms
  • Neoplasms
  • Pharyngeal Neoplasms
  • Recurrence
  • Recurrent Cutaneous Melanoma
  • Recurrent Lip and Oral Cavity Carcinoma
  • Recurrent Malignant Endocrine Neoplasm
  • Recurrent Malignant Female Reproductive System Neoplasm
  • Recurrent Malignant Male Reproductive System Neoplasm
  • Recurrent Malignant Mesothelioma
  • Recurrent Malignant Neoplasm of Multiple Primary Sites
  • Recurrent Malignant Oral Neoplasm
  • Recurrent Malignant Pharyngeal Neoplasm
  • Recurrent Malignant Skin Neoplasm
  • Recurrent Malignant Soft Tissue Neoplasm
  • Recurrent Malignant Solid Neoplasm
  • Recurrent Malignant Thyroid Gland Neoplasm
  • Recurrent Malignant Urinary System Neoplasm
  • Refractory Cutaneous Melanoma
  • Refractory Malignant Bone Neoplasm
  • Refractory Malignant Endocrine Neoplasm
  • Refractory Malignant Female Reproductive System Neoplasm
  • Refractory Malignant Male Reproductive System Neoplasm
  • Refractory Malignant Mesothelioma
  • Refractory Malignant Neoplasm of Multiple Primary Sites
  • Refractory Malignant Oral Neoplasm
  • Refractory Malignant Pharyngeal Neoplasm
  • Refractory Malignant Skin Neoplasm
  • Refractory Malignant Soft Tissue Neoplasm
  • Refractory Malignant Solid Neoplasm
  • Refractory Malignant Thyroid Gland Neoplasm
  • Refractory Malignant Urinary System Neoplasm
  • Sarcoma
  • Skin Neoplasms
  • Soft Tissue Neoplasms
  • Thyroid Diseases
  • Thyroid Neoplasms
  • Urologic Neoplasms

NCT number NCT03420963
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Demetrios Petropoulos, MD
Phone 713-792-3746
Email dpetro@mdanderson.org
Status Recruiting
Phase Phase 1
Start date August 31, 2018
Completion date December 1, 2027

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