Dendritic cells are the major antigen presenting cells which stimulate naive as well as memory T cells to mount antitumor immunity. Because of inhibition of immune responses in tumor microenvironment, it is believed that ex vivo generation of tumor antigen pulsed mature DCs and reinfusion to tumor bearing patients will result in tumor specific immune responses. To address this issue, in this phase I/II cliniocal tria, 20 patient with pediatrics brain tumor will vaccinated with autologous tumor antigen pulsed DCs three times and immunological and clinical responses as well as side effects will assayed in a three mounth follow up.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016080829257N1
Registration date:2016-11-04, 1395/08/14
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-11-04, 1395/08/14
Registrant information
Name
Nowruz Delirezh
Name of organization / entity
Urmia University
Country
Iran (Islamic Republic of)
Phone
+98 44 3344 0198
Email address
n.delirezh@urmia.ac.ir
Recruitment status
Recruitment complete
Funding source
Ministry of Health and Medical Education
Expected recruitment start date
2017-01-01, 1395/10/12
Expected recruitment end date
2019-01-01, 1397/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Immunotherapy of pediatric patients with brain tumor using autologous tumor - lysate pulsed dendritic cells in a phase I/II clinical trial
Public title
Immunotherapy of pediatric brain cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Brain tumor without metastases or recurrence; glioma; meduloblastoma; CD4>350 cell/mm; 3-18 months ≤ age ≤15 years; 10Kg ≤Weight; Confirmation of informed consent; Normal serum tests; Immunotherapy should be started at least 3 wks after last chemo or radiotherapy course
Exclusion criteria:
Cardiovascular-pulmnary diseases; Hepatitis B, C or HIV infections; tumor pressure on spinal cord; Patient who will need chemo or radiotherapy during immunotherapy; 470ms≤Improved QT; ECG disorders; corticosteroides administration
Age
From 1 year old to 15 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Urmia University of Medical Science Ethic Committee
Street address
Resalat Bvd, Urmia University of Medical Science Campus
Generation of immature dendritic cells from isolated monocytes of patients, pulsing of DCs with autologous tumor lysate, induction of maturation in DCs, reinfusion of mature DCs to patient
This study is planned as phase I/II clinical trial, so no control group is considered
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia University of Medical Science
Full name of responsible person
Dr Nowruz Delirezh
Street address
Institute of Biotechnology
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Urmia University of Medical Science
Full name of responsible person
Dr Iraj Mohebbi
Street address
Vice President of Research
City
Urmia
Grant name
پروژه ایمونوتراپی سرطان مغز
Grant code / Reference number
14000245577
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urmia University of Medical Science
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
Institute of Biotechnology, Urmia University
Full name of responsible person
Dr Nowruz Delirezh
Position
Chairman
Other areas of specialty/work
Street address
Urmia University
City
Urmia
Postal code
571794454
Phone
+98 44 3344 0199
Fax
+98 44 3344 0199
Email
delirezhn@gmail.com
Web page address
www.biotechinst.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Institute of Biotechnology, Urmia University
Full name of responsible person
Dr Nowruz delirezh
Position
Chairman
Other areas of specialty/work
Street address
Urmia University
City
Urmia
Postal code
571794454
Phone
+98 44 3344 0199
Fax
+98 44 3344 0199
Email
delirezhn@gmail.com
Web page address
ww.biotechinst.ir
Person responsible for updating data
Contact
Name of organization / entity
Institute of Biotechnology
Full name of responsible person
Dr Nowruz delirezh
Position
Chairman
Other areas of specialty/work
Street address
Institute of Biotechnology, Urmia University
City
Urmia
Postal code
571794454
Phone
+98 44 3344 0199
Fax
+98 44 3344 0199
Email
delirezhn@gmail.com
Web page address
www.biotechinst.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)