CEA-Expressing Liver Metastases Safety Study of Intrahepatic Infusions of Anti-CEA Designer T Cells
Completed · Phase 1
Conditions studied: Liver Metastases
In brief
The purpose of this study is to collect data on the safety and potential effectiveness of 2nd generation designer T cells delivered into the hepatic circulation in patients with liver metastases expressing the CEA tumor marker. Designer T cells are prepared by collecting white blood cells from the participant, and then modifying these cells in the laboratory so that they recognize the tumor antigen, CEA. These modified cells are then given back into the participant so that they can attack and kill tumor cells. The investigators hypothesize that regional delivery of the designer T cells directly into the hepatic artery will minimize systemic toxicity and optimize the changes for therapeutic effect.
Key facts
- Study ID
- NCT01373047
- Run by
- Roger Williams Medical Center
- People needed
- 8
- Starts
- 2011-06-01
- Expected to finish
- 2013-07-01
- Last updated by the study team
- 2013-07-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed diagnosis of CEA+ adenocarcinoma and liver metastases
- Liver metastases must be CEA-expressing as demonstrated by elevated serum CEA levels (≥10ng/ml) or immunohistochemistry on a biopsy specimen
- Failure on at least one line of standard systemic chemotherapy and have unresectable liver disease
- Measurable liver disease (> 1.0 cm by CT or MRI)
- Extrahepatic disease is acceptable when limited to the lungs and/or abdominal lymph nodes
- At least 18 years of age
- Able to understand and sign informed consent
- Life expectancy of greater than four months
- Good performance status (PS 0-1)
You may not qualify if…
- Pregnancy
- Serious medical conditions including but not limited to liver, cardiopulmonary, and renal disease
- Patients with a history of portal hypertension, cirrhosis, hepatitis, or with radiographic evidence of cirrhosis
- Concurrent malignancy
- Use of systemic steroids
Where it is running
- Roger Williams Medical Center — Providence, Rhode Island, United States
Full record on ClinicalTrials.gov
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