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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03329664
Other study ID # Autologous Killer cell therapy
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date February 9, 2020
Est. completion date January 2022

Study information

Verified date March 2021
Source Sabz Biomedicals
Contact Naser Ahmadbeigi, Ph.D
Phone +9821-82415103
Email n-ahmadbeigi@sina.tums.ac.ir
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to evaluate the safety and efficacy of activated and expanded autologous cytokine-killer cells in controlling disease recurrence in colon cancer patients with liver metastasis. 20 patients with confirmed stage IV colon carcinoma with metastasis will be assigned into two groups. Patients in both groups will receive the same therapeutic regimen as usual. Patients in one group additionally will be treated with a single infusion of autologous killer cells that had been previously prepared from peripheral blood.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date January 2022
Est. primary completion date September 2021
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria: - Patients with histologically confirmed colorectal cancer at stage IV - ECOG performance status 0-2 - Adequate cardiac/renal/hepatic function - Adequate bone marrow function (blood cell count) Exclusion Criteria: - Patients that have received prior chemotherapy or immune cell therapy - Patients that have previously participated in another clinical trial - History of positive test result for HIV, HBV, HCV, HTLV-1, syphilis - Presence of Active infections - Patients with immunodeficiencies, autoimmunities, or severe allergies - Receiving immunosuppressive regimens

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Cytokine-induced killer cell
Immune-cell therapy with CIK cells
Other:
Chemotherapy AND/OR Radiation Therapy
Routine treatments for colon cancer patients according to their stage

Locations

Country Name City State
Iran, Islamic Republic of Gene Therapy Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences Tehran

Sponsors (3)

Lead Sponsor Collaborator
Sabz Biomedicals Digestive Diseases Research Institute, Tehran University of Medical Sciences, Iran, Ministry of Health and Medical Education

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety of administering CIK cells plus chemotherapy Patients will be continually assessed for unexpected adverse events or unexpected early mortality 30 days post infusion one month post infusion
Primary Progression-free Survival (PFS) The time from treatment initiation day to first documented progressive disease or death due to disease. 2 years
Primary Time to progression (TTP) the time from randomization until cancer progression, not including death. 2 years
Secondary Overall survival (OS) The length of time that the patients are still alive at a defined period of time after treatment 2 years
Secondary Patient quality of life Quality of patients enrolling in the study assessed using EORTC-CR29 questionnaire each 3 months for 2 years
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