A Pilot Study of Radiation-Immune Cell Combination Therapy in Cervical Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Uterine Cervical Neoplasms |
Biological: Immune cells Radiation: Low dose radiation |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study of Radiation-Immune Cell Combination Therapy in Recurrent or Persistent Cervical Cancer |
- Response rate [ Time Frame: 12months ] [ Designated as safety issue: Yes ]Response rate according to RECIST criteria for 12 months
- Toxicity [ Time Frame: 12months ] [ Designated as safety issue: Yes ]Toxcity according to CTCSEver4.0
| Estimated Enrollment: | 10 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Radiation and 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 cells
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
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients must have signed an approved informed consent and authorization permitting release of personal health information.
- Age 18-75 years
Pathologically proven recurrent or persistent cervical cancer patients resistant to conventional palliative chemotherapy or radiation therapy
- Persistent tumor more than 1cm after initial chemoradiation or radiation therapy
- Persistent tumor more than 1cm after chemoradiation, radiation or chemotherapy in recurrent cervical cancer
- Metastatic cervical cancer to lung resistant to conventional chemotherapy
- ECOG performance status 0, 1, 2.
- Expected survival more than 3 months
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,
- More than 3 weeks from the last day of previous chemotherapy or radiation
Exclusion Criteria:
- Patients with immune disease or auto-immune disease (ex. rheumatoid arthritis, SLE, immune vasculitis, IDDM)
- Immune deficiency disease
- Cancers other than cervical cancer within 5 years
- Acute myocardial infarction, uncontrolled hypertension
- Severe allergic disease
- Severe psychotic disease
- Those who can be a candidate for curative surgery
Contacts and Locations| Contact: Sang-Young Ryu, MD | 82-2-970-1227 | ryu@kcch.re.kr |
| Contact: JaeGeum Lee, Bachelor | 82-2-970-2347 | gmi0916@hanmail.net |
| Korea, Republic of | |
| Sang-Young Ryu | Recruiting |
| Seoul, Nowon‐Gu, Korea, Republic of, 139-706 | |
| Contact: Sang Young Ryu, MD 82-2-970-1227 ryu@kcch.re.kr | |
| Contact: JaeGeum Lee, Bachelor 82-2-970-2347 gmi0916@hanmail.net | |
| Principal Investigator: Sang-Young Ryu, MD | |
| Principal Investigator: | Sang-Young Ryu, MD | Korea Institute of Radiological & Medical Sciences |
More Information
No publications provided
| Responsible Party: | Sang-Young Ryu, A staff at department of obstetrics and gynecology, Korea Institute of Radiological & Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT01194609 History of Changes |
| Other Study ID Numbers: | RadImmune Cx-1001 |
| Study First Received: | September 2, 2010 |
| Last Updated: | October 9, 2011 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Korea Institute of Radiological & Medical Sciences:
|
Low dose radiation Adoptive immune cell therapy Cervical cancer Pilot study |
Additional relevant MeSH terms:
|
Neoplasms Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms |
Neoplasms by Site Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 16, 2013