Trials / Completed
CompletedNCT04657315
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
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- CHA University · Academic / Other
- Sex
- All
- Age
- 19 Years – 70 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 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 |
Timeline
- Start date
- 2020-06-24
- Primary completion
- 2022-12-22
- Completion
- 2022-12-22
- First posted
- 2020-12-08
- Last updated
- 2023-01-18
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT04657315. Inclusion in this directory is not an endorsement.