Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Rare Diseases

Recurrence

Glioblastoma

Brain Neoplasms

Neoplasms, Germ Cell and Embryonal

Central Nervous System Neoplasms

Nervous System Neoplasms

Gliosarcoma

Disease Attributes

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Brain Diseases

Central Nervous System Diseases

Neuroepithelioma

Anti-Infective Agents

All Drugs and Chemicals

Flucytosine

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

MSC11FCD

Kyunggi Cho, MD,PhD

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.

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

Investigator-initiated and Open-labeled Clinical Trial for Evaluation of Maximum Tolerated Dose, Safety and Efficiency of MSC11FCD Therapy to Recurrent Glioblastoma Patients

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)

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)

OS is defined as the time from the date of MSC injection to the date of death due to any cause.

The progress-free survival analysis shall be 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.

Karnofsky performance status (KPS) assessment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluation of Maximum Tolerated Dose, Safety and Efficiency of MSC11FCD Therapy to Recurrent Glioblastoma Patients	NCT04657315	Glioblastoma Adult Gliosarco... Neoplasms, Brai... Neoplasms, Germ... Recurrent Gliob...	MSC11FCD	19 Years - 70 Years	CHA University
Evaluation of Maximum Tolerated Dose, Safety and Efficiency of MSC11FCD Therapy to Recurrent Glioblastoma Patients	NCT04657315	Glioblastoma Adult Gliosarco... Neoplasms, Brai... Neoplasms, Germ... Recurrent Gliob...	MSC11FCD	19 Years - 70 Years	CHA University

Spots Global Cancer Trial Database for neoplasms, germ cell