Investigator-initiated and Open-labeled Clinical Trial for Evaluation of Maximum Tolerated Dose, Safety and Efficiency of MSC11FCD Therapy to Recurrent Glioblastoma Patients

CHA University1 site in 1 country10 target enrollmentJune 24, 2020

ConditionsGlioblastoma Adult Gliosarcoma Neoplasms, Brain Neoplasms, Germ Cell and Embryonal Recurrent Glioblastoma

InterventionsMSC11FCD

DrugsMSC11FCD

Overview

Phase: Phase 1
Intervention: MSC11FCD
Conditions: Glioblastoma
Sponsor: CHA University
Enrollment: 10
Locations: 1
Primary Endpoint: Maximum tolerated dose (MTD)
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

Not Provided

Registry

clinicaltrials.gov

Start Date

June 24, 2020

End Date

December 22, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

CHA University

Responsible Party

Principal Investigator

Kyung GI, CHO

Professor

CHA University

Eligibility Criteria

Inclusion Criteria

•Patients aged 19 to 70
•Patients diagnosed with recurrent glioblastoma based on medical imaging after receiving standard therapy for glioblastoma
•Patients scheduled to undergo surgical treatment for recurrent glioblastoma
•Patients diagnosed with recurrent glioblastoma based on medical imaging (MRI: conventional, diffusion, perfusion, spectroscopy) and confirmed to have tumor cells during surgery based on frozen biopsy
•Patients whose expected survival period is at least 3 months
•Patients who have not received any other types of immunotherapy
•Patients who have been given a sufficient explanation of the purpose and details of the clinical trial and the characteristics of the investigational drug from an investigator and who signed the consent form or had a legal guardian or representative sign the consent form prior to the beginning of this clinical trial
•Patients who have waited for at least four weeks after treatment using cytotoxic drugs in order to eliminate the possibility of impact and effects from other therapeutic agents (23 days after the last administration in case of undergoing standard therapy using temozolomide)

Exclusion Criteria

•Patients who have primary glioblastoma
•Patients with dihydropyrimidine dehydrogenase (DPD) deficiency
•Patients who cannot undergo a contrast (gadolinium) enhanced MRI scan due to a certain condition (pacemaker, etc.) or cannot undergo an MRI scan according to the clinical trial schedule due to any other reasons
•Patients to whom Gliadel water was applied during surgery
•Patients who are deemed to have a serious dysfunction in any of the major organs (liver, kidneys, bone marrow, lungs, heart) by the investigator
•Patents who have other types of malignant tumor aside from glioblastoma or who have had malignant tumor in the past 5 years
•Patients who uncontrolled hypotension or hypertension
•Diabetic patients who are currently receiving insulin therapy or who need insulin therapy
•Patients who are deemed to have a serious infectious disease by the investigator: sepsis, hepatitis A, hepatitis B or hepatitis C (in the case of hepatitis B and C viruses, however, carriers may be enrolled at the investigator's discretion) or tested positive in a serological test for the human immunodeficiency virus (HIV)
•Karnofsky Performance Scale \< 60

Arms & Interventions

The investigational drug into the Intratumoral administration

The investigational drug in the amount of 1x10\^7, 3x10\^7cells per dose into the tumor or the tumor removal site using a syringe during surgery

Intervention: MSC11FCD

Outcomes

Primary Outcomes

Maximum tolerated dose (MTD)

Time Frame: after treatment discontinuation for approximately 1 years

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)

Number Of Adverse Events related to the treatment

Time Frame: Baseline, Day0, 1 month, 3 months, 6 months, 12 months

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)

Secondary Outcomes

Overall Survival improvement (OS)(Study entry through the end of the study, up to 12 months)
Progression Free Survival (PFS)(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(At Baseline, 1month, 3months, 6months, 12months)
Clinical efficacy assessment(At Baseline, 1month, 3months, 6months, 12months)