- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04657315
Evaluation of Maximum Tolerated Dose, Safety and Efficiency of MSC11FCD Therapy to Recurrent Glioblastoma Patients (MSC11FCD-GBM)
Investigator-initiated and Open-labeled Clinical Trial for Evaluation of Maximum Tolerated Dose, Safety and Efficiency of MSC11FCD Therapy to Recurrent Glioblastoma Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Kyunggido
-
Seongnam, Kyunggido, Korea, Republic of, 13496
- Bundang Cha Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
after treatment discontinuation for approximately 1 years
|
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)
|
Baseline, Day0, 1 month, 3 months, 6 months, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival improvement (OS)
Time Frame: 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.
|
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
|
The progress-free survival analysis shall be based on the RANO criteria.
|
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
|
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. |
At Baseline, 1month, 3months, 6months, 12months
|
Clinical efficacy assessment
Time Frame: At Baseline, 1month, 3months, 6months, 12months
|
Karnofsky performance status (KPS) assessment
|
At Baseline, 1month, 3months, 6months, 12months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kyunggi Cho, MD,PhD, CHA University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Astrocytoma
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Nerve Tissue
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Neoplasms
- Neoplasms, Germ Cell and Embryonal
- Glioblastoma
- Recurrence
- Brain Neoplasms
- Gliosarcoma
Other Study ID Numbers
- CHAMC 2019-08-022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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