Protocol summary
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Study aim
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Evaluation of using mesenchymal stem cells containing thymidine kinase gene in patients with glioblastoma multiforme.
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Design
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A clinical trial with a control group, with parallel groups, randomized, phase 2 on 40 patients. The randomization function of Excel software was used for randomization.
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Settings and conduct
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Forty patients with glioblastoma confirmed by two pathologists in this study will be randomly divided into control and gene therapy groups (twenty patients in each group). Patients will be screened every three months until the tumor recurs and dies. The study site will be Shohada Tajrish Hospital.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Karnofsky performance status> 70. Adequate hematological function (an absolute neutrophil count > 1500/μl and platelet count > 125000/mm3). Adequate renal function (creatinine < 1.5 times the normal). Adequate hepatic function (aspartate aminotransferase and bilirubin < 1.5 times the normal). Patients who fill informed consent. Exclusion criteria: Significant vascular disease. History of recurrent thromboembolism. Prior history of hypertensive crisis or hypertensive encephalopathy. Gastrointestinal fistula or perforation. History of an intraabdominal or intracranial abscess within 6 months. Serious non-healing wound, ulcer and bone fracture.
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Intervention groups
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Intervention group: A total of 5 ^ 10 × 5 mesenchymal stem cells carrying with thymidine kinase gene are injected into the evacuated tumor site under the guidance of a brain navigation device. After cell injection, ganciclovir should be administered for a total of 28 doses over 14 days.
Control group: In this group, patients receive standard chemotherapy and radiotherapy.
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Main outcome variables
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Overall survival; progression-free survival.
General information
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Reason for update
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Given the ease of availability, isolation, and preparation process as well as less associated morbidity for patients, allogeneic cell source was also added to the study. This change was made in the study title.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200502047277N3
Registration date:
2020-10-13, 1399/07/22
Registration timing:
registered_while_recruiting
Last update:
2024-03-24, 1403/01/05
Update count:
1
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Registration date
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2020-10-13, 1399/07/22
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-07-23, 1398/05/01
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Expected recruitment end date
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2023-07-23, 1402/05/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Intracerebral Administration of Allogeneic/Autologous Mesenchymal Stem Cells as HSV-TK Gene Vehicle to Treatment of Glioblastoma: Clinical Trial Phase II
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Public title
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Evaluation of the effect of stem cell-mediated gene therapy in the treatment of glioblastoma
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Karnofsky performance status> 70.
Adequate hematological function (an absolute neutrophil count > 1500/μl and platelet count > 125000/mm3).
Adequate renal function (creatinine < 1.5 times the normal).
Adequate hepatic function (aspartate aminotransferase and bilirubin < 1.5 times the normal).
Patient who fill informed consent.
Exclusion criteria:
Significant vascular disease.
History of recurrent thromboembolism.
Prior history of hypertensive crisis or hypertensive encephalopathy.
Gastrointestinal fistula or perforation.
History of intraabdominal or intracranial abscess within 6 months.
Serious non healing wound, ulcer and bone fracture.
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Age
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From 18 years old to 70 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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No information
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-12-07, 1398/09/16
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Ethics committee reference number
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IR.NIMAD.REC.1399.026
Health conditions studied
1
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Description of health condition studied
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Glioma grade 4
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ICD-10 code
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C71
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ICD-10 code description
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Malignant neoplasm of cerebellum
Primary outcomes
1
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Description
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Overall survival (OS) of patients
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Timepoint
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Before treatment and every three months until the patient's death
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Method of measurement
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The time from treatment initiation until patient's death
2
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Description
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Radiological progression free survival (PFS) of patients
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Timepoint
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Before treatment and every three months until the disease recurrence
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Method of measurement
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The time from treatment initiation until disease progression or worsening
Intervention groups
1
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Description
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Intervention group: In this group of patients, bone marrow stem cells were isolated after tumor evacuation. Then 5 ^ 10 × 5 mesenchymal stem cells infected with thymidine kinase-carrying lentivirus are injected into the evacuated tumor site under the guidance of a brain navigation device. After cell injection, ganciclovir should be administered for a total of 28 doses over 14 days.
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Category
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Treatment - Other
2
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Description
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Control group: In this group, patients receive standard chemotherapy and radiotherapy.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available