Glioblastoma multiform is one of the most invasive and deadly cancers that progresses rapidly and leads to death. Surgery with radiotherapy /chemotherapy, as a treatment approach is ineffective in some cases and is associated with relapse and death. Immunotherapy is a special strategy that used as an adjunct therapy in various cancers and among the various methods of immunotherapy; it seems that cell therapy with NK cells is of special importance. A previous study conducted at the Royan Research Institute showed that NK cell proliferation and amplification resulted in the removal of glioblastoma tumor masses in the animal model. The animals had no evidence of tumor recurrence after treatment, and all tumor-related complications resolved after treatment. Therefore, in this study, the investigators intend to evaluate the safety of ex vivo activated cells in 5 patients with glioblastoma multiform whose disease has returned after treatment and who have not had any appropriate treatment.
1- patient selection 2- leukapheresis 3- CD56+ cells isolation 4- NK cells activation 5- assessment of functionality and purity 6- quality control tests 7-NK cell injection in tumor cavity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Activated NK cell injection in tumor cavity of patient with GBM (Glioblastoma Multiform)
Royan institute
Tehran, Iran
RECRUITINGToxicity assay
Toxicity as assessed by NCI CTCAE version 3.0
Time frame: 4 weeks of last injection
Adverse Events (AEs)
Defined as the number and severity of adverse events
Time frame: 1 year
Safety evaluation
Safety evaluated by assessing the medical symptoms measurement: Fever, Hysteria and Convulsion
Time frame: From injection time point up to 48 hours
Safety evaluation
Safety evaluated by assessing the medical symptoms measurement: Meningitis, Neurological disorders
Time frame: 2 months after injection
Safety evaluation
Safety evaluated by assessing the medical symptoms measurement: Loss of consciousness
Time frame: From injection time point up to 8 weeks
MRI and MRS from the tumor region
Defined tumoral residua and tumor cell recurrence
Time frame: 1 months after last dose of NK cell injection up to 1 year each 3 months
Patient survival
Evaluation of patient's life extension followed by NK cell therapy
Time frame: After surgery up to an average of 1 year
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