Study Stopped
\<75% participation
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
3 other identifiers
interventional
12
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2018
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2018
CompletedFirst Posted
Study publicly available on registry
February 5, 2018
CompletedStudy Start
First participant enrolled
August 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 26, 2026
CompletedMarch 20, 2026
March 1, 2026
7.5 years
January 29, 2018
March 17, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence of adverse events
Since toxicity is the primary outcome, patients with non-measurable disease (who are still evaluable) will be included in the analysis and in these cases standard methods for categorizing response of non-measurable disease will be used. Toxicity rate will be estimated separately by dose and cohort along with a 95% confidence interval. Adverse events will be tabulated for all the patients separately by dose levels.
Up to 30 days after the NK cell infusion
Maximum tolerated dose and/or recommended phase 2 dose of cord blood-derived expanded allogeneic natural killer (NK) cells following chemotherapy
Primary analyses in this phase I trial are descriptive and exploratory. Toxicity rate will be estimated separately by dose and cohort along with a 95% confidence interval. Adverse events will be tabulated for all the patients separately by dose levels.
Up to 30 days after the NK cell infusion
Secondary Outcomes (4)
Response rate per immune-related therapy trials Response Evaluation Criteria in Solid Tumors (irRECIST)
Up to 30 days after the NK cell infusion
NK cell persistence, phenotype, and function
Up to 30 days after the NK cell infusion
Overall survival (OS)
Up to 30 days after the NK cell infusion
Time to progression (TTP)
Up to 30 days after the NK cell infusion
Study Arms (1)
Treatment (cyclophosphamide, etoposide, NK cells)
EXPERIMENTALPatients receive cyclophosphamide IV 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.
Interventions
Given IV
Given IV
Given IV
Eligibility Criteria
You may qualify if:
- SCREENING: Patients with relapsed or refractory solid tumors and without known curative therapy or therapy proven to proven to prolong survival with acceptable quality of life.
- SCREENING: Patients older than 21 years must have a solid tumor considered by study doctor to be of the childhood cancer type.
- SCREENING: Performance level as measured by Karnofsky \>= 60% for patients \> 16 years of age or Lansky \>= 60% for patients =\< 16 years of age.
- SCREENING: Documentation of measurable or evaluable non-measurable disease.
- SCREENING: At least one documented histological verification of solid tumor diagnosis. Can be from original diagnosis or more recent.
- ENROLLMENT: Patient must have fully recovered (i.e. returned to baseline) from the clinically significant acute treatment-related toxicities of all prior treatments prior to beginning treatment on this protocol with exceptions of cytopenias resulting from persistent disease, hearing loss and alopecia.
- ENROLLMENT: Performance level as measured by Karnofsky \>= 60% for patients \> 16 years of age or Lansky \>= 60% for patients =\< 16 years of age.
- ENROLLMENT: Creatinine clearance \>= 60 mL/min/1.73m\^2 (calculated by 24 hour \[h\] urine collection or nuclear glomerular filtration rate \[GFR\] scan if 24 h collection is not possible) or a serum creatinine based on age and gender as follows:
- Age, maximum serum creatinine (mg/dL):
- month to \< 6 months, male 0.4, female 0.4;
- months to \< 1 year, male 0.5, female 0.5;
- to \< 2 years, male 0.6, female 0.6;
- to \< 6 years, male 0.8, female 0.8;
- to \< 10 years, male 1, female 1;
- to \< 13 years, male 1.2, female 1.2;
- +10 more criteria
You may not qualify if:
- SCREENING: Primary tumors of the central nervous system.
- SCREENING: Chronic corticosteroid dependence that is unable to be weaned to discontinue.
- ENROLLMENT: Uncontrolled arrhythmias or uncontrolled symptoms of cardiac disease noted by screening history and physical. Patients with known cardiac dysfunction should have an ejection fraction (EF) \> 40% documented by echocardiogram (ECHO).
- ENROLLMENT: Patients where the burden of pulmonary metastasis, location, or bulkiness of disease may cause high morbidity if localized swelling such as causing uncontrolled symptoms, oxygen dependence, or location near a major bronchi as determined by investigator.
- ENROLLMENT: Pregnant females.
- ENROLLMENT: Any uncontrolled systemic infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Demetrios Petropoulos
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2018
First Posted
February 5, 2018
Study Start
August 31, 2018
Primary Completion
February 26, 2026
Study Completion
February 26, 2026
Last Updated
March 20, 2026
Record last verified: 2026-03