Evaluation of using bone marrow mesenchymal stem cells containing lentivirus carrying thymidine kinase gene in patients with glioblastoma multiforme.
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Control group: In this group, patients receive standard chemotherapy and radiotherapy.
Main outcome variables
Overall survival; progression-free survival.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200502047277N3
Registration date:2020-10-13, 1399/07/22
Registration timing:registered_while_recruiting
Last update:2020-10-13, 1399/07/22
Update count:1
Registration date
2020-10-13, 1399/07/22
Registrant information
Name
saeed oraee yazdani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 25719
Email address
saeed_o_yazdani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Intracerebral Administration of Autologous Mesenchymal Stem Cells as HSV-TK Gene Vehicle to Treatment of Glioblastoma: Clinical Trial Phase II
Public title
Evaluation of the effect of stem cell-mediated gene therapy in the treatment of glioblastoma
Purpose
Treatment
Inclusion/Exclusion criteria
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.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Institute for Medical Research Development of the Islamic Republic of Iran
Street address
National Institute of Medical Research Development, No. 21, Besat St., West Fatemi St., Tehran, Iran,
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۶۹۳۱۱۱
Approval date
2019-12-07, 1398/09/16
Ethics committee reference number
IR.NIMAD.REC.1399.026
Health conditions studied
1
Description of health condition studied
Glioma grade 4
ICD-10 code
C71
ICD-10 code description
Malignant neoplasm of cerebellum
Primary outcomes
1
Description
Overall survival (OS) of patients
Timepoint
Before treatment and every three months until the patient's death
Method of measurement
The time from treatment initiation until patient's death
2
Description
Radiological progression free survival (PFS) of patients
Timepoint
Before treatment and every three months until the disease recurrence
Method of measurement
The time from treatment initiation until disease progression or worsening
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Other
2
Description
Control group: In this group, patients receive standard chemotherapy and radiotherapy.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
Saeed Oraee Yazdani
Street address
Shohadaye Tajrish hospital, Tajrish Square.
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
Saeed_o_yazdani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
7th Floor, Building Number. 2, Shahid Beheshti University of Medical Sciences, Arabi Avenue, Daneshjoo Boulevard, Velenjak, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2243 9770
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?