This is a phase I trial evaluating the maximum tolerated dose, safety and efficiency of Mesenchymal stem cells into which the suicide gene, cytosine deaminase (CD), injected into the resection cavity of patients with recurrent glioblastoma.
Not Provided
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Administration period: Single dose Route of administration: Intratumoral administration Dose: 1x10\^7, 3x10\^7cells/dose Summary: Administer the investigational drug in the amount of 1x107, 3x107cells per dose into the tumor or the tumor removal site using a syringe during surgery. Concomitant drug: 5-Flucytosine (prodrug) Dose: 150mg/kg/day Directions: Administration period and directions: Administer 150m of 5-Flucytosine per kilogram of body weight every 6 hours for a total of 4 times a day (QID) for a duration of 7 days after surgery. Route of administration: Oral administration
Bundang CHA Medical Center
Seongnam, Kyunggido, South Korea
Maximum tolerated dose (MTD)
Assessment of the maximum tolerated dose based on the 3+3 method * Blood concentrations of 5-FC and 5-FU(Day 1, Day 3, Day 7) * MSC11FCD concentrations (MSCCD detection) (Day 0, 3months, 6months, 12months)
Time frame: after treatment discontinuation for approximately 1 years
Number Of Adverse Events related to the treatment
Evaluate the number of adverse event related to the treatment according to CTCAE V4.0 during the trial (including clinically significant changes in physical examination, radiographic images, safety lab tests, vital signs)
Time frame: Baseline, Day0, 1 month, 3 months, 6 months, 12 months
Overall Survival improvement (OS)
OS is defined as the time from the date of MSC injection to the date of death due to any cause.
Time frame: Study entry through the end of the study, up to 12 months
Progression Free Survival (PFS)
The progress-free survival analysis shall be based on the RANO criteria.
Time frame: Study entry through the end of the study, up to 12 months
Tumor assessment in regard to the investigational drug based on the RANO criteria
Assess the treatment groups participating in this clinical trial based on the RANO criteria. Compare and present the disease control rates by calculating the ratio of the number of subjects responding to treatment (complete response: CR, partial response: PR, stable disease: SD) among the treatment groups and control group assessed based on the RANO criteria.
Time frame: At Baseline, 1month, 3months, 6months, 12months
Clinical efficacy assessment
Karnofsky performance status (KPS) assessment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: At Baseline, 1month, 3months, 6months, 12months