Designing Clinical Trial for Immunotherapy of Metastatic Colorectal Cancer Patients by Autologous Cancer Vaccine

Designing Clinical Trial for Immunotherapy of Metastatic Colorectal Cancer Patients by Autologous Cancer Vaccine
Safoora Mohammadzadeh,^1,* Mohammad Hassan Emami,² Samane Mohammadzadeh,³ Fatemeh Maghool,⁴
1. Poursina Hakim Digestive Diseases Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
2. Poursina Hakim Digestive Diseases Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
3. Poursina Hakim Digestive Diseases Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
4. Poursina Hakim Digestive Diseases Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
Introduction: Colorectal Cancer (CRC) is the second leading cause of cancer-related mortality. This disease has an adverse effect on the quality of life. Surgery and chemotherapy are standard methods for improving quality of life, reducing the number of tumors, and reducing metastases. In recent years, immunotherapy with cancer vaccines has been used to induce appropriate immune responses against cancer cells or tumor antigens. One of the cancer vaccines and active specific immunotherapies for CRC patients is an autologous colon cancer vaccine which used after surgery. This vaccine contains the sterile non-tumorigenic autologous tumor cells and BCG (Calmette-Guerin bacillus) in 4 doses injection after chemotherapy. The aim of this study is a different design of clinical trial in Iran for immunotherapy of colorectal cancer patients by autologous cancer vaccine.
Methods: We designed the distinct clinical trials schedule for immunotherapy of colorectal cancer patients by autologous cancer vaccine. This cancer vaccine will be able to use for 1; metastatic colorectal cancer patients, 2; all patients with resectable or non-resectable tumors can use this vaccine. 3; this immunotherapy has two additional doses (6 doses instead of 4 doses of common vaccine) in two periods, 3 doses will be injected before the chemotherapy and also 3 doses will be injected after the chemotherapy.
Results: This new different designing of clinical trials schedule for immunotherapy of metastatic colorectal cancer patients by non-tumorigenic autologous tumor cells was approved in Isfahan University of medical sciences and also Iranian Registry of Clinical Trials.
Conclusion: It is the first time autologous tumor cells have been used in an Iranian clinical trial. As a result of this study, patients with metastatic CRC can receive active specific aimmunotherapies at lower costs in Iran.
Keywords: Autologous Cancer Vaccine, Colorectal Cancer, Metastasis, Immunotherapy, Clinical Trial