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

Launched by M.D. ANDERSON CANCER CENTER · Feb 1, 2018

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment for children and young adults who have solid tumors that have either come back after treatment or have not responded to previous therapies. The study is looking at using special white blood cells called donor natural killer (NK) cells, which are collected from umbilical cord blood, along with two chemotherapy drugs, cyclophosphamide and etoposide. The goal is to find out the best doses of these treatments and see how effective they are in fighting these tough tumors.

To participate in this trial, patients must be between the ages of 1 and 21, with a solid tumor that has no known effective treatments left. They should be in decent overall health, meaning they have recovered from past treatments and meet certain health criteria. Participants will receive the NK cells and chemotherapy, and the study team will closely monitor their health and any side effects. It’s important to note that this trial is still recruiting patients, so there are opportunities for eligible individuals to join the study and contribute to this important research.

Gender

ALL

Eligibility 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.