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

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.

Conditions

• 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

Interventions

BIOLOGICAL

Cord Blood-derived Expanded Allogeneic Natural Killer Cells

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Etoposide

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Demetrios Petropoulos · M.D. Anderson Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

12 Months

Max Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-08-31

Primary Completion

2026-02-26

Completion

2026-02-26

FDA Drug

Yes

Countries

• United States

Study Locations