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

NCT01194609TerminatedPHASE1, PHASE2INTERVENTIONAL

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 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.

Key Facts

Lead Sponsor

Korea Cancer Center Hospital

Enrollment

Start Date

2010-09-01

Completion Date

2011-09-01

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Immune cellLow dose radiation

Conditions

Uterine Cervical Neoplasms

Eligibility

Age Range

18 Years – 75 Years

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Response rate

Response rate according to RECIST criteria for 12 months

Time frame: 12months

Secondary Outcomes

Toxicity

Toxcity according to CTCSEver4.0

Time frame: 12months

Locations

Sang-Young Ryu, Seoul, South Korea