k cell therapy for recurrent GBM (Glioblastoma Multiform)

Phase 1

Recruiting

Conditions: Recurrent Glioblastoma Multiform(GBM) and resistant/recurrent malignant brain tumor.
Malignant neoplasm of brain, unspecified
C71.9

Registration Number: IRCT20170122032121N5

Lead Sponsor: Iranian academic center for education culture and research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 5

Inclusion Criteria

Age: 3-65 Year
Sex: Both
Lansky/Karnofsky performance statue: 7-100%
Life span expectation: >6 months
Hemoglobin: > 10.0 g/dL
AGC > 1,500/mm³
Platelet count > 100,000/mm³
Serum total bilirubin < 1.5 times upper limit of normal(ULN)
ALT and AST < 2.5 times ULN
Serum creatinine < 1.5 times

Exclusion Criteria

Patients whose MRI or MRS view of the brain is in favor of radio necrosis
Due to emergency conditions, the patient can not tolerate the new treatment
Insufficient number of NK cells produced for treatment
appearance new neurological ulcers after the first injection (after the wound heals, subsequent injections will be given if the patient is in good condition)
diagnosis of any other invasive cancer within the past 5 years.
Closing the reservare for the next injection (if this problem is solved, the injections will be done again.
concurrent serious medical or psychiatric illness that may interfere with giving informed consent or conducting this study

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fever. Timepoint: After cell injection, every 2 hours up to 48 hours after cell injection. Method of measurement: Fever meter.;Hysteria. Timepoint: After cell injection, control the symptom up to 48 hours. Method of measurement: Patient checkup.;New neurological symptoms which not related to the tumor. Timepoint: Up to 48 hours after surgery, up to one week after cell injection. Method of measurement: Physical examination and recording of symptoms.

Secondary Outcome Measures

Name	Time	Method
Tumor size. Timepoint: One week after injection, every 2 weeks up to 3 months. Method of measurement: MRI and MRS.;Patient's survival. Timepoint: Every month up to 6 months. Method of measurement: Communicate with patients.