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

NCT ID: NCT04657315

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-24
• Study Completion Date: 2022-12-22

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

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

MSC11FCD

Intervention Type: DRUG

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

Interventions

MSC11FCD

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

Intervention Type: DRUG

Other Intervention Names

Mesenchymal stem cells into which the suicide gene, cytosine deaminase (CD)

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ajou University School of Medicine

OTHER

Sponsor Role: collaborator

CHA University

OTHER

Sponsor Role: lead

Responsible Party

Kyung GI, CHO

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kyunggi Cho, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

CHA University

Locations

Bundang CHA Medical Center

Seongnam, Kyunggido, South Korea

Countries

South Korea

Other Identifiers

CHAMC 2019-08-022

Identifier Type: -

Identifier Source: org_study_id