GlioblastomaPhase 1/2MSC11FCD-GBMNCT04657315
Evaluation of Maximum Tolerated Dose, Safety and Efficiency of MSC11FCD Therapy to Recurrent Glioblastoma Patients
A Phase 1/2 study testing MSC11FCD in people with Glioblastoma and Adult Gliosarcoma, run by CHA University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Glioblastoma, Adult Gliosarcoma, Neoplasms, Brain
- What is being tested?
- MSC11FCD
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Jun 2020to 22 Dec 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 15Show fewer
- 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
- Patients with an autoimmune disease affecting the central nervous system (multiple sclerosis, myasthenia gravis, acute disseminated encephalomyelitis, etc.)
- Patients with a history of allergic reactions to flucytosine (5-FC) and/or its excipients or 5-fluorouracil (5-FU)
- Pregnant or lactating women or patients who plan on getting pregnant during the clinical trial or refuses to choose an appropriate method of contraception
- Patients who have participated in a different clinical trial no more than 30 days prior to registering for this clinical trial
- Patients who are deemed to be unfit for this clinical trial by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
Not Provided
- Conditions
- Glioblastoma, Adult Gliosarcoma, Neoplasms, Brain, Neoplasms, Germ Cell and Embryonal, Recurrent Glioblastoma
- Being tested
- MSC11FCD
- Keywords
- Glioblastoma, Mesenchymal stem cells, Brain Tumor, Neoplasms, Germ Cell, Flucytosine, Central Nervous System Neoplasms
- Medical subject headings
- Glioblastoma, Gliosarcoma, Brain Neoplasms, Neoplasms, Germ Cell and Embryonal, Central Nervous System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSC11FCDDrug
Also called Mesenchymal stem cells into which the suicide gene, cytosine deaminase (CD)
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
| Study group | Role | What they receive |
|---|---|---|
| The investigational drug into the Intratumoral administration | Other | 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 Receives: Drug: MSC11FCD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: Baseline, Day0, 1 month, 3 months, 6 months, 12 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: At Baseline, 1month, 3months, 6months, 12months
Clinical efficacy assessment
Karnofsky performance status (KPS) assessment
Measured: At Baseline, 1month, 3months, 6months, 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start24 Jun 2020
- Primary completion22 Dec 2022
- Study completion22 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHA University
- Sponsor type
- University, hospital or other
- Collaborators
- Ajou University School of Medicine
- Responsible party
- Principal investigator, Kyung GI, CHO, CHA University
- Investigators
- Kyunggi Cho, MD,PhD, Principal investigator, CHA University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657315
- Sponsor's protocol ID
- CHAMC 2019-08-022
- Acronym
- MSC11FCD-GBM
- Status last verified
- Jan 2023
- First submitted
- 1 Nov 2020
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04657315
- Acronym / sponsor ID
- MSC11FCD-GBM / CHAMC 2019-08-022
- 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
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- CHA UniversityUniversity, hospital or other
- Collaborators
- Ajou University School of Medicine
- Study start
- 24 Jun 2020 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 8 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The investigational drug into the Intratumoral administration | Other | Drug: MSC11FCDThe 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 |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSC11FCDAlso: Mesenchymal stem cells into which the suicide gene, cytosine deaminase (CD)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 | Drug | The investigational drug into the Intratumoral administration |
Primary outcome
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)
4 secondary outcomes
Overall Survival improvement (OS)
Time frame: Study entry through the end of the study, up to 12 months
Progression Free Survival (PFS)
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
Time frame: At Baseline, 1month, 3months, 6months, 12months
Clinical efficacy assessment
Time frame: At Baseline, 1month, 3months, 6months, 12months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Glioblastoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Glioblastoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyunggi Cho, MD,PhD principal investigator
CHA University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MSC11FCD in people with Glioblastoma and Adult Gliosarcoma, run by CHA University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) (time frame: after treatment discontinuation for approximately 1 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.