A Pilot Study of Radiation-Immune Cell Combination Therapy in Cervical Cancer
|ClinicalTrials.gov Identifier: NCT01194609|
Recruitment Status : Terminated (No further enrollment after two patients)
First Posted : September 3, 2010
Last Update Posted : May 9, 2014
|Condition or disease||Intervention/treatment||Phase|
|Uterine Cervical Neoplasms||Biological: Immune cell Radiation: Low dose radiation||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Radiation-Immune Cell Combination Therapy in Recurrent or Persistent Cervical Cancer|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||April 2012|
Experimental: Low dose radiation, Immune cell therapy
Combination treatment of low-dose radiation 20cGy every 3 weeks three times and autologous immune cell therapy 2 consecutive weeks 3 times every 3 weeks
Biological: Immune cell
InnoLak two consecutive weeks every 3 weeks for 3 times
Other Name: InnoLAKRadiation: Low dose radiation
20cGy whole body radiation every three weeks for three times
Other Name: Whole body radiation
- Response rate [ Time Frame: 12months ]Response rate according to RECIST criteria for 12 months
- Toxicity [ Time Frame: 12months ]Toxcity according to CTCSEver4.0
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01194609
|Korea, Republic of|
|Seoul, Nowon‐Gu, Korea, Republic of, 139-706|
|Principal Investigator:||Sang-Young Ryu, MD||Korea Institute of Radiological & Medical Sciences|