Clinical trial NCT04657315: Evaluation of Maximum Tolerated Dose, Safety and Efficiency of MSC11FCD Therapy to Recurrent Glioblastoma Patients
Official title: Investigator-initiated and Open-labeled Clinical Trial for Evaluation of Maximum Tolerated Dose, Safety and Efficiency of MSC11FCD Therapy to Recurrent Glioblastoma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Glioblastoma
Adult Gliosarcoma
Neoplasms, Brain
Neoplasms, Germ Cell and Embryonal
Recurrent Glioblastoma
Keywords: Glioblastoma, Mesenchymal stem cells
Brain Tumor
Neoplasms, Germ Cell
Flucytosine
Central Nervous System Neoplasms
Lead sponsor: CHA University
Sponsor class: OTHER
Collaborators: name: Ajou University School of Medicine
First posted: 2020-12-08
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

1. Patients aged 19 to 70
2. Patients diagnosed with recurrent glioblastoma based on medical imaging after receiving standard therapy for glioblastoma
3. Patients scheduled to undergo surgical treatment for recurrent glioblastoma
4. 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
5. Patients whose expected survival period is at least 3 months
6. Patients who have not received any other types of immunotherapy
7. 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
8. 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:

1. Patients who have primary glioblastoma
2. Patients with dihydropyrimidine dehydrogenase (DPD) deficiency
3. 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
4. Patients to whom Gliadel water was applied during surgery
5. Patients who are deemed to have a serious dysfunction in any of the major organs (liver, kidneys, bone marrow, lungs, heart) by the investigator
6. Patents who have other types of malignant tumor aside from glioblastoma or who have had malignant tumor in the past 5 years
7. Patients who uncontrolled hypotension or hypertension
8. Diabetic patients who are currently receiving insulin therapy or who need insulin therapy
9. 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)
10. Karnofsky Performance Scale \< 60
11. Patients with an autoimmune disease affecting the central nervous system (multiple sclerosis, myasthenia gravis, acute disseminated encephalomyelitis, etc.)
12. Patients with a history of allergic reactions to flucytosine (5-FC) and/or its excipients or 5-fluorouracil (5-FU)
13. Pregnant or lactating women or patients who plan on getting pregnant during the clinical trial or refuses to choose an appropriate method of contraception
14. Patients who have participated in a different clinical trial no more than 30 days prior to registering for this clinical trial
15. Patients who are deemed to be unfit for this clinical trial by the investigator

Primary outcomes:
measure: Maximum tolerated dose (MTD)
timeFrame: after treatment discontinuation for approximately 1 years
measure: Number Of Adverse Events related to the treatment
timeFrame: Baseline, Day0, 1 month, 3 months, 6 months, 12 months
Secondary outcomes:
measure: Overall Survival improvement (OS)
timeFrame: Study entry through the end of the study, up to 12 months
measure: Progression Free Survival (PFS)
timeFrame: Study entry through the end of the study, up to 12 months
measure: Tumor assessment in regard to the investigational drug based on the RANO criteria
timeFrame: At Baseline, 1month, 3months, 6months, 12months
measure: Clinical efficacy assessment
timeFrame: At Baseline, 1month, 3months, 6months, 12months
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Bundang CHA Medical Center
state: Kyunggido
Study officials:
affiliation: CHA University
name: Kyunggi Cho, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: