Phase
Condition
Lung Cancer
Malignant Melanoma
Sarcoma
Treatment
Cyclophosphamide
Cord Blood-derived Expanded Allogeneic Natural Killer Cells
Etoposide
Clinical Study ID
Ages 12-40 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
SCREENING: Patients with relapsed or refractory solid tumors and without knowncurative therapy or therapy proven to proven to prolong survival with acceptablequality of life.
SCREENING: Patients older than 21 years must have a solid tumor considered by studydoctor to be of the childhood cancer type.
SCREENING: Performance level as measured by Karnofsky >= 60% for patients > 16 yearsof 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 tumordiagnosis. Can be from original diagnosis or more recent.
ENROLLMENT: Patient must have fully recovered (i.e. returned to baseline) from theclinically significant acute treatment-related toxicities of all prior treatmentsprior to beginning treatment on this protocol with exceptions of cytopeniasresulting from persistent disease, hearing loss and alopecia.
ENROLLMENT: Performance level as measured by Karnofsky >= 60% for patients > 16years 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 collectionis 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 pyruvatetransaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x upper limit of normal (ULN) for age (unless Gilbert's disease or abnormal liver function due to primarydisease).
ENROLLMENT: Evidence of adequate bone marrow function (defined by absoluteneutrophil count >= 750), unless patient has documented tumor metastasis to the bonemarrow or other condition that results in cytopenia without abnormal marrowfunction.
ENROLLMENT: Evidence of adequate bone marrow function (defined by platelets >= 50,000), unless patient has documented tumor metastasis to the bone marrow or othercondition that results in cytopenia without abnormal marrow function.
ENROLLMENT: Pulmonary symptoms controlled by medication and pulse oximetry >= 92% onroom air.
ENROLLMENT: Sexually active males and females of childbearing potential must agreeto use a form of contraception considered effective and medically acceptable by theinvestigator. (Non-childbearing potential defined as pre-menarche, greater than oneyear post-menopausal or surgically sterilized).
ENROLLMENT: Confirmation that a cord blood donor which is matched with the recipientat a 4, 5, or 6/6 human leukocyte antigen (HLA) class I (serological) and HLA classII (molecular) antigens.
ENROLLMENT: Signed informed consent and if applicable pediatric assent.
Exclusion
Exclusion Criteria:
SCREENING: Primary tumors of the central nervous system.
SCREENING: Chronic corticosteroid dependence that is unable to be weaned todiscontinue.
SCREENING: Determined by study doctor that patient is unlikely to meet inclusioncriteria after screening.
ENROLLMENT: Uncontrolled arrhythmias or uncontrolled symptoms of cardiac diseasenoted by screening history and physical. Patients with known cardiac dysfunctionshould have an ejection fraction (EF) > 40% documented by echocardiogram (ECHO).
ENROLLMENT: Patients where the burden of pulmonary metastasis, location, orbulkiness of disease may cause high morbidity if localized swelling such as causinguncontrolled symptoms, oxygen dependence, or location near a major bronchi asdetermined by investigator.
ENROLLMENT: Pregnant females.
ENROLLMENT: Any uncontrolled systemic infection.
Study Design
Study Description
Connect with a study center
M D Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
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