Autologous Killer cell therapy in colorectal cancer patients
Phase 1
- Conditions
- Stage IV colon cancer.Malignant neoplasm of colon
- Registration Number
- IRCT20170726035311N2
- Lead Sponsor
- Deputy of Research, Digestive Disease Research Institute, Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Patients with histologically confirmed colorectal cancer at stage IV,
The male patient of = 40 and <60 years of age,
Eastern Cooperative Oncology Group (ECOG) performance status 0-2,
Adequate cardiac/renal/hepatic function,
Adequate bone marrow function (blood cell count).
Exclusion Criteria
History positive test result for HIV, HBV, HCV, HTLV-1, syphilis.
Presence of Active infections upon blood collection.
Immunodeficiencies, autoimmunities,severe allergies, reviving immuno-suppression regimen.
History of participating in other clinical trials.
History of drug abuse.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence percentage of adverse events (vomiting, pyrexia, headache, cough) following infusion. Timepoint: Measuring body temperature and clinical examination by physician before infusion, on the day of infusion and on days 7, 14 and 21 post infusion. Method of measurement: Thermometer, Questionnaire.;Percent of patients with progression-free survival (PFS). Timepoint: every 4 weeks during treatment, every 2-3 months after treatment, for 2 years. Method of measurement: CT, MRI, medical examination.;Time to progression (TTP). Timepoint: every 4 weeks during treatment, every 2-3 months after treatment, for 2 years. Method of measurement: CT, MRI, medical examination.
- Secondary Outcome Measures
Name Time Method Overall survival (OS),. Timepoint: 2 years. Method of measurement: Kaplan-Meier estimator,.;Quality of Life. Timepoint: ?Every 3 month and for 2 years. Method of measurement: Questionnaire.