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Autologous Killer Cell Therapy in Colon Cancer Patients

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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

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.

Condition or disease Intervention/treatment Phase
Colon Cancer Stage II/III Biological: Cytokine-induced killer cell Other: Chemotherapy AND/OR Radiation Therapy Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Safety and Efficacy of ex Vivo Activated and Expanded Autologous Cytokine-induced Killer Cells for Colon Cancer Patients
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : January 2022

Arm Intervention/treatment
Experimental: CIK Intervention plus routine treatment
Patients who receive their routine treatment (chemotherapy, radiation therapy) + Cytokine-induced killer cell infusion
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

Active Comparator: Control
Patients who receive routine treatments only (chemotherapy, radiation therapy)
Other: Chemotherapy AND/OR Radiation Therapy
Routine treatments for colon cancer patients according to their stage




Primary Outcome Measures :
  1. 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

  2. Progression-free Survival (PFS) [ Time Frame: 2 years ]
    The time from treatment initiation day to first documented progressive disease or death due to disease.

  3. Time to progression (TTP) [ Time Frame: 2 years ]
    the time from randomization until cancer progression, not including death.


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03329664


Contacts
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Contact: Naser Ahmadbeigi, Ph.D +9821-82415103 n-ahmadbeigi@sina.tums.ac.ir

Locations
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Iran, Islamic Republic of
Cell-based Therapies Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences Active, not recruiting
Tehrān, Iran, Islamic Republic of
Sponsors and Collaborators
Sabz Biomedicals
Ministry of Health and Medical Education
Digestive Diseases Research Institute, Tehran University of Medical Sciences, Iran
Investigators
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Principal Investigator: Naser Ahmadbeigi, Ph.D Cell-based Therapies Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran

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Responsible Party: Naser Ahmadbeigi, Doctor, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03329664     History of Changes
Other Study ID Numbers: Autologous Killer cell therapy
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases