Using donor natural killer cells with chemotherapy to treat relapsed solid tumors in children and young adults
Ex-Vivo Expanded Allogeneic NK Cells for the Treatment of Solid Tumors of Pediatric Origin in Children and Young Adults
This study is testing whether adding special immune cells from cord blood to chemotherapy can help children and young adults with relapsed solid tumors feel better and fight their cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 12 Months to 40 Years |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, cyclophosphamide |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT03420963 on ClinicalTrials.gov |
What this trial studies
This phase I trial investigates the safety and optimal dosage of expanded allogeneic natural killer (NK) cells derived from cord blood, in combination with the chemotherapy drugs cyclophosphamide and etoposide, for treating children and young adults with relapsed or refractory solid tumors. The study aims to determine how well these NK cells can persist and function after chemotherapy, as well as their preliminary antitumor activity. Participants will receive chemotherapy followed by NK cell infusion, with follow-up assessments to monitor their response and any side effects.
Who should consider this trial
Good fit: Ideal candidates include children and young adults with relapsed or refractory solid tumors that lack known curative therapies.
Not a fit: Patients with solid tumors that have effective curative treatments available may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for children and young adults with difficult-to-treat solid tumors.
How similar studies have performed: While this approach is innovative, similar studies using NK cells in cancer treatment have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 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):
* 1 month to \< 6 months, male 0.4, female 0.4;
* 6 months to \< 1 year, male 0.5, female 0.5;
* 1 to \< 2 years, male 0.6, female 0.6;
* 2 to \< 6 years, male 0.8, female 0.8;
* 6 to \< 10 years, male 1, female 1;
* 10 to \< 13 years, male 1.2, female 1.2;
* 13 to \< 16 years, male 1.5, female 1.4;
* \>= 16 years, male 1.7, female 1.4.
* ENROLLMENT: Adequate liver function, defined as: total bilirubin =\< 2 mg/dl
* ENROLLMENT: Adequate liver function, as defined as serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 2.5 x upper limit of normal (ULN) for age (unless Gilbert's disease or abnormal liver function due to primary disease).
* ENROLLMENT: Evidence of adequate bone marrow function (defined by absolute neutrophil count \>= 750), unless patient has documented tumor metastasis to the bone marrow or other condition that results in cytopenia without abnormal marrow function.
* ENROLLMENT: Evidence of adequate bone marrow function (defined by platelets \>= 50,000), unless patient has documented tumor metastasis to the bone marrow or other condition that results in cytopenia without abnormal marrow function.
* ENROLLMENT: Pulmonary symptoms controlled by medication and pulse oximetry \>= 92% on room air.
* ENROLLMENT: Sexually active males and females of childbearing potential must agree to use a form of contraception considered effective and medically acceptable by the investigator. (Non-childbearing potential defined as pre-menarche, greater than one year post-menopausal or surgically sterilized).
* ENROLLMENT: Confirmation that a cord blood donor which is matched with the recipient at a 4, 5, or 6/6 human leukocyte antigen (HLA) class I (serological) and HLA class II (molecular) antigens.
* ENROLLMENT: Signed informed consent and if applicable pediatric assent.
Exclusion Criteria:
* SCREENING: Primary tumors of the central nervous system.
* SCREENING: Chronic corticosteroid dependence that is unable to be weaned to discontinue.
* SCREENING: Determined by study doctor that patient is unlikely to meet inclusion criteria after screening.
* 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.
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Demetrios Petropoulos — M.D. Anderson Cancer Center
- Study coordinator: Demetrios Petropoulos, MD
- Email: dpetro@mdanderson.org
- Phone: 713-792-3746
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.