ACTIVE_NOT_RECRUITING

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Ex-Vivo Expanded Allogeneic NK Cells for the Treatment of Solid Tumors of Pediatric Origin in Children and Young Adults

Quick Facts

Study Start:2018-08-31

Study Completion:2027-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03420963

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Months to 40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

Demetrios Petropoulos

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Demetrios Petropoulos, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-08-31

Study Completion Date2027-12-01

Study Record Updates

Study Start Date2018-08-31

Study Completion Date2027-12-01

Terms related to this study

Additional Relevant MeSH Terms

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