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

This study has been terminated.
(No further enrollment after two patients)
Sponsor:
Information provided by (Responsible Party):
Sang-Young Ryu, Korea Cancer Center Hospital
ClinicalTrials.gov Identifier:
NCT01194609
First received: September 2, 2010
Last updated: May 7, 2014
Last verified: May 2014

September 2, 2010
May 7, 2014
September 2010
September 2011   (final data collection date for primary outcome measure)
Response rate [ Time Frame: 12months ] [ Designated as safety issue: Yes ]
Response rate according to RECIST criteria for 12 months
Same as current
Complete list of historical versions of study NCT01194609 on ClinicalTrials.gov Archive Site
Toxicity [ Time Frame: 12months ] [ Designated as safety issue: Yes ]
Toxcity according to CTCSEver4.0
Same as current
Not Provided
Not Provided
 
A Pilot Study of Radiation-Immune Cell Combination Therapy in Cervical Cancer
A Pilot Study of Radiation-Immune Cell Combination Therapy in Recurrent or Persistent Cervical Cancer

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. Recently, the low-dose radiation is known to increase the immune response in many human cancer patients. In a clinical trial, 70% response rate with combination of low-dose radiation and adoptive immune cell therapy was reported in recurrent melanoma patients. 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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Uterine Cervical Neoplasms
  • Biological: Immune cell
    InnoLak two consecutive weeks every 3 weeks for 3 times
    Other Name: InnoLAK
  • Radiation: Low dose radiation
    20cGy whole body radiation every three weeks for three times
    Other Name: Whole body radiation
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
Interventions:
  • Biological: Immune cell
  • Radiation: Low dose radiation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
April 2012
September 2011   (final data collection date for primary outcome measure)

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
Female
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01194609
RadImmune Cx-1001
Yes
Sang-Young Ryu, Korea Cancer Center Hospital
Korea Cancer Center Hospital
Not Provided
Principal Investigator: Sang-Young Ryu, MD Korea Institute of Radiological & Medical Sciences
Korea Cancer Center Hospital
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP