A Pilot Study of Radiation-Immune Cell Combination Therapy in Recurrent or Persistent Cervical Cancer
Immune cell therapy is considered one of the most promising anti-cancer strategy in many
human cancers. Compared to the destructive methods such as surgery, radiation, and
chemotherapy, anti-cancer immune therapy is safer and less toxic method in the treatment of
human cancer patients.
Among the immune cell therapy, autologous adoptive immune cell therapy is a method to
transfer the immune cells derived from peripheral white blood cells and expanded and
stimulated with various cytokines and tumor specific antigens in cancer patients. Recent
development of the technique to expand immune cells ex vivo make autologous adoptive immune
cell therapy much more feasible and popular. However, immune cell therapy showed response of
below 10% currently in several clinical trials. The reason of poor response is that the
adopted immune cells have to overcome the highly immune compromised environment in advanced
or recurrent cancer patients.
The low-dose radiation, defined as the radiation below the therapeutic dose range, is known
to increase the immune response in many human cancer patients. Despite the exact mechanism
is not well known, the 'danger signal' and the decrease of T-regulatory cells by low-dose
radiation are the possible mechanism of enhanced immunity by low-dose radiation. So, the
combination of low-dose radiation and immune cell therapy can be a attractive strategy to
recurrent or advanced cancer patients who are resistant to conventional treatment.
A challenging clinical trial performed in recurrent melanoma cancers, Dr. Rosenverg reported
around 70% response rate with combination of low-dose radiation and adoptive immune cell
therapy. However, the feasibility of combination of low-dose radiation and immune cell
therapy is still unknown in many human cancers.
This study is to investigate the feasibility of combination of low-dose radiation and
autologous immune cell therapy in recurrent cervical cancer which is resistant to
conventional palliative treatment. The cervical cancer, highly responsive to radiation,
becomes resistant to radiation in case of recurrent disease. We hypothetize that if the
low-dose radiation can reverse the immune compromised environment, adoptive immune cells
derived from the autologous peripheral blood immune cells will be highly effective in
recurrent cervical cancers.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate according to RECIST criteria for 12 months
Sang-Young Ryu, MD
Korea Institute of Radiological & Medical Sciences
Korea: Food and Drug Administration