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Autologous Killer Cell Therapy in Colon Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03329664
Recruitment Status : Not yet recruiting
First Posted : November 6, 2017
Last Update Posted : April 5, 2019
Sponsor:
Collaborators:
Ministry of Health and Medical Education
Digestive Diseases Research Institute, Tehran University of Medical Sciences, Iran
Information provided by (Responsible Party):
Naser Ahmadbeigi, Tehran University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE October 30, 2017
First Posted Date  ICMJE November 6, 2017
Last Update Posted Date April 5, 2019
Estimated Study Start Date  ICMJE April 2019
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2017)
  • Safety of administering CIK cells plus chemotherapy [ Time Frame: one month post infusion ]
    Patients will be continually assessed for unexpected adverse events or unexpected early mortality 30 days post infusion
  • Progression-free Survival (PFS) [ Time Frame: 2 years ]
    The time from treatment initiation day to first documented progressive disease or death due to disease.
  • Time to progression (TTP) [ Time Frame: 2 years ]
    the time from randomization until cancer progression, not including death.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03329664 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2017)
Overall survival (OS) [ Time Frame: 2 years ]
The length of time that the patients are still alive at a defined period of time after treatment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Killer Cell Therapy in Colon Cancer Patients
Official Title  ICMJE Safety and Efficacy of ex Vivo Activated and Expanded Autologous Cytokine-induced Killer Cells for Colon Cancer Patients
Brief 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 colon carcinoma who have had complete resection of primary lesions 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 several infusions of autologous killer cells that had been previously prepared from peripheral blood.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Colon Cancer Stage II/III
Intervention  ICMJE
  • Biological: Cytokine-induced killer cell
    Immune-cell therapy with CIK cells
    Other Name: CIK
  • Other: Chemotherapy AND/OR Radiation Therapy
    Routine treatments for colon cancer patients according to their stage
Study Arms  ICMJE
  • Experimental: CIK Intervention plus routine treatment
    Patients who receive their routine treatment (chemotherapy, radiation therapy) + Cytokine-induced killer cell infusion
    Interventions:
    • Biological: Cytokine-induced killer cell
    • Other: Chemotherapy AND/OR Radiation Therapy
  • Active Comparator: Control
    Patients who receive routine treatments only (chemotherapy, radiation therapy)
    Intervention: Other: Chemotherapy AND/OR Radiation Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 30, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with histologically confirmed colorectal cancer at stage II/III
  • Male patient aged at 40-60 years' old
  • undergone prior complete resection of the primary lesions (colorectal cancer)
  • ECOG performance status 0-2
  • Adequate cardiac/renal/hepatic function
  • Adequate bone marrow function (blood cell count)

Exclusion Criteria:

  • Female patients
  • 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 sever allergies
  • Receiving immunosuppressive regimens
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 40 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Naser Ahmadbeigi, Ph.D +9821-82415103 n-ahmadbeigi@sina.tums.ac.ir
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03329664
Other Study ID Numbers  ICMJE Autologous Killer cell therapy
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Naser Ahmadbeigi, Tehran University of Medical Sciences
Study Sponsor  ICMJE Sabz Biomedicals
Collaborators  ICMJE
  • Ministry of Health and Medical Education
  • Digestive Diseases Research Institute, Tehran University of Medical Sciences, Iran
Investigators  ICMJE
Principal Investigator: Naser Ahmadbeigi, Ph.D Cell-based Therapies Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran
PRS Account Sabz Biomedicals
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP