Status:
TERMINATED
A Pilot Study of Radiation-Immune Cell Combination Therapy in Cervical Cancer
Lead Sponsor:
Korea Cancer Center Hospital
Conditions:
Uterine Cervical Neoplasms
Eligibility:
FEMALE
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
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 cytok...
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 im...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01194609
Start Date
September 1 2010
End Date
April 1 2012
Last Update
May 9 2014
Active Locations (1)
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1
Sang-Young Ryu
Seoul, Nowon-Gu, South Korea, 139-706