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A Pilot Study of Radiation-Immune Cell Combination Therapy in Recurrent or Persistent Cervical Cancer

Phase 1/Phase 2
18 Years
75 Years
Open (Enrolling)
Uterine Cervical Neoplasms

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Trial Information

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.

Inclusion Criteria:

1. Patients must have signed an approved informed consent and authorization permitting
release of personal health information.

2. Age 18-75 years

3. Pathologically proven recurrent or persistent cervical cancer patients resistant to
conventional palliative chemotherapy or radiation therapy

1. Persistent tumor more than 1cm after initial chemoradiation or radiation therapy

2. Persistent tumor more than 1cm after chemoradiation, radiation or chemotherapy
in recurrent cervical cancer

3. Metastatic cervical cancer to lung resistant to conventional chemotherapy

4. ECOG performance status 0, 1, 2.

5. Expected survival more than 3 months

6. Patients must have adequate:

Hematologic function: ANC ≥ 1,500/mcl, Hemoglobin >10g/dL, platelets ≥ 100,000/mcl
Renal function: creatinine ≤ 1.5 x ULN Hepatic function: AST, ALT ≤ 1.5 x ULN,

7. More than 3 weeks from the last day of previous chemotherapy or radiation

Exclusion Criteria:

1. Patients with immune disease or auto-immune disease (ex. rheumatoid arthritis, SLE,
immune vasculitis, IDDM)

2. Immune deficiency disease

3. Cancers other than cervical cancer within 5 years

4. Acute myocardial infarction, uncontrolled hypertension

5. Severe allergic disease

6. Severe psychotic disease

7. Those who can be a candidate for curative surgery

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Description:

Response rate according to RECIST criteria for 12 months

Outcome Time Frame:


Safety Issue:


Principal Investigator

Sang-Young Ryu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Korea Institute of Radiological & Medical Sciences


Korea: Food and Drug Administration

Study ID:

RadImmune Cx-1001



Start Date:

September 2010

Completion Date:

September 2012

Related Keywords:

  • Uterine Cervical Neoplasms
  • Low dose radiation
  • Adoptive immune cell therapy
  • Cervical cancer
  • Pilot study
  • Neoplasms
  • Uterine Cervical Neoplasms