Cyclosporine as an immunosuppressive drug is widely used in patient undergoing transplant surgeries. Glioblastoma multiforme is one of the aggressive tumors that still has no pivotal treatment. In animal models the effect of cyclosporine on preventing tumor growth and invasion is observed. These studies are in the initial phase of the clinical trial and efficacy of the drug in humans has not been established yet. This study is designed to evaluate the efficacy of cyclosporine on preventing tumor growth and invasion of GBM. The study is a single blind randomized clinical trial. Survival of patients after one year of treatment in this study will be presented. For this purpose, patients whom brain MRI and intraoperative frozen section represent the GBM diagnosis would be treated with cyclosporine. The drug delivery starts immediately after the surgery with the dose of Neuroprotective effects in trauma cases which is documented in literature. Infusion of 2.5 mg/kg over first 2 hours and will be continued with the dose of 5mg/kg /day for 72 hours.
In this study, 40 patients will be recruited and will be visited every month and evaluated with Karnofsky score. Any decline in the indicators of this scale is recorded. Based on tumor location and amount of tumor resection patients are classified into SUBTOTAL, NEAR TOTAL & GTR. The beneficial effect of cyclosporine on 1 year survival of patients will be evaluated with Karnofsky score.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201512028612N3
Registration date:2016-01-22, 1394/11/02
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2016-01-22, 1394/11/02
Registrant information
Name
Amir Sarayani
Name of organization / entity
Research Center for Rational Use of Drugs
Country
Iran (Islamic Republic of)
Phone
+98 21 8881 4157
Email address
a-sarayanib@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Science, Shariati Hospital
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Clinical trial to assess the effects of short-term administration of cyclosporine on survival of patients with glioblastoma multiforme tumor surgery
Public title
Effect of an immuno-suppresive medication (cyclosporine) on brain tumor patients survival
Purpose
Treatment
Inclusion/Exclusion criteria
Exclusion:
Inclusion:
GBM diagnosis in brain MRI and GBM confirmation in frozen section
Exclusion:
History of previous surgery of GBM tumor
Only biopsy plan of surgery for patient
Pregnancy
Positive viral markers
Hepatic or renal impairment
Impaired lipid profile
Fever or infection
Elderly above 90 years old
Age
From 18 years old to 90 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences, Ethics Committee
Street address
Ghods junction, Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2015-06-17, 1394/03/27
Ethics committee reference number
IR.TUMS.REC.1394.76
Health conditions studied
1
Description of health condition studied
glioblastoma multiform
ICD-10 code
C71.9
ICD-10 code description
Malignant neoplasm of brain/unspecified
Primary outcomes
1
Description
Performance Status (Survival)
Timepoint
measured every 2 months after recruitment up to one year
Method of measurement
Karnofsky Performance Status Scale
Secondary outcomes
empty
Intervention groups
1
Description
Infusion of 2.5 mg/kg cyclosporine over first 2 hours post operation and will be continued with the dose of 5mg/kg /day for 72 hours
Category
Treatment - Drugs
2
Description
control group:
routine care of post op GBM patients
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Dr Khoshnevisan
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr khoshnevisan
Street address
Shariati Hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr Farzaneh
Position
MD
Other areas of specialty/work
Street address
Shariati Hospital
City
Tehran
Postal code
Phone
+98 21 8490 2272
Fax
Email
ff1353@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Khoshnevisan
Position
MD
Other areas of specialty/work
Street address
Shariati Hospital
City
Tehran
Postal code
Phone
+98 21 8490 2272
Fax
Email
akhoshnevisan@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Farzaneh
Position
MD
Other areas of specialty/work
Street address
Shariati Hospital
City
Tehran
Postal code
Phone
+98 21 8490 2272
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)