Neuroblastoma. Malignant neoplasm of unspecified part of unspecified adrenal gland
Conditions
Interventions
Intervention group: NK cells that were isolated by CliniMACS from apheresis samples will be expanded over 10 days in a specific media with 10% serum and will be infused in combination with cyclophosph
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
1 Years to 15 Years
Inclusion criteria
Inclusion criteria: Any amount of neuroblastoma tumor cells in the bone marrow that can be seen from at least one aspiration sample Tumors seen on CT in at least one soft tissue. Have at least 1 MIBG- lesion with a score of 1-2 Curie The patient has a life expectancy of at least 12 weeks. The function of the patients organs must be acceptable. Patient age from 1 to 15 years
Exclusion criteria
Exclusion criteria: Active or uncontrollable infection History of allergies or any hypersensitivity to animal proteins Heart failure Serious mental and physical disabilities Participation in any other clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To measure tumor response after infusion of expanded activated NK cells. Response will be assessed as defined by Revised International Neuroblastoma Response Criteria 2017. Timepoint: Each 6 month Over 2 years. Method of measurement: Disease status at primary and metastatic soft tissue sites will be assessed using MIBG scans or PET scan as applicable. | — |
Secondary
| Measure | Time frame |
|---|---|
| To measure the numbers of infused NK cells in peripheral blood at specific time-points after NK cell infusion. Timepoint: before intervention and 2, 4 , 6 month after intervention. Method of measurement: NK cells will be identified by flow cytometry in peripheral blood and their percentages and absolute numbers will be calculated. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactRashin Mohseni
Tehran University of Medical Sciences
Outcome results
None listed