Evaluation of Maximum Tolerated Dose, Safety and Efficiency of MSC11FCD Therapy to Recurrent Glioblastoma Patients

Phase 1

Completed

• Conditions: Neoplasms, Germ Cell and Embryonal; Recurrent Glioblastoma; Glioblastoma; Neoplasms, Brain; Adult Gliosarcoma
• Interventions: Drug: MSC11FCD

• Registration Number: NCT04657315
• Lead Sponsor: CHA University

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

Study Timeline

• Study Start: 2020-06-24
• Study First Submitted: 2020-11-01
• Study First Submitted QC: 2020-12-05
• Study First Posted: 2020-12-08
• Primary Completion: 2022-12-22
• Study Completion: 2022-12-22
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-14
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The investigational drug into the Intratumoral administration	MSC11FCD	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

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD)	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	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 Outcome Measures

Name	Time	Method
Overall Survival improvement (OS)	Study entry through the end of the study, up to 12 months	OS is defined as the time from the date of MSC injection to the date of death due to any cause.
Progression Free Survival (PFS)	Study entry through the end of the study, up to 12 months	The progress-free survival analysis shall be based on the RANO criteria.
Tumor assessment in regard to the investigational drug based on the RANO criteria	At Baseline, 1month, 3months, 6months, 12months	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.
Clinical efficacy assessment	At Baseline, 1month, 3months, 6months, 12months	Karnofsky performance status (KPS) assessment

Trial Locations

Locations (1)

Bundang CHA Medical Center; 🇰🇷 Seongnam, Kyunggido, Korea, Republic of