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Phase I Intratumoral Dendritic Cell Immunotherapy in Thermally Ablated Liver Metastases
Trial ID: NCT00185874
Up to twenty-two patients will be enrolled in this study to receive autologous dendritic cells (DCs) administered intratumorally into liver metastases following radiofrequency thermal ablation of those lesions. Patients will receive two vaccinations of DCs at monthly intervals. A dose escalation study of DCs will be included in this study in an attempt to define the maximum tolerated dose of administered DCs.
A Phase I Trial of Intratumoral Dendritic Cell Immunotherapy in Thermally Ablated Liver Metastases
Inclusion Criteria:- Patients must have a histologically confirmed colorectal or
neuroendocrine cancer with two or more hepatic metastatic lesions.
- Patients must have unresectable liver metastasis by virtue of:
- Bi-lobar disease.
- Extra-hepatic disease.
- Patients for whom there are medical contraindications to surgery.
- Anatomic sites within the liver that in the opinion of our surgeon would likely
be left with positive margin.
- Patient must have a minimum of 2 RFA-eligible lesion in the liver. Such as hepatic
lesions that are 5 cm or smaller and that are accessible to RF ablation, which in
general excludes sites contiguous with critical structures such as bowel or central
bile duct and also those that are not amenable to radiographic localization such as
small lesions in the dome of the liver. Extra-hepatic disease will be allowed provided
that the liver lesions represent the most life-threatening site for that patient.
Examples include sub centimeter asymptomatic lung metastases or asymptomatic
retroperitoneal lymph nodes or peritoneal metastases
- Evaluable disease by CT scan or MRI in addition to the lesions to be treated with RFA.
- More than 4 weeks must have elapsed from the time of major surgery or completion of
the last dose of chemotherapy, radiation therapy, investigational therapy and patients
must adequately recover from these effects.
- Life expectancy of >3 months.
- Karnofsky performance status >70%.
- Patients must have normal organ and marrow functions as defined below:
- absolute neutrophil count >1,500/mm^3
- platelets >70,000/mm^3
- total bilirubin <1.5 mg/dL
- AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
- creatinine within normal institutional limits OR
- creatinine clearance >60mL/min/1.73 m^2 for patients with creatinine levels above
- albumin > 2.8 mg/dL
- Patients must have adequate clotting function (platelet > 70k; INR<1.4; PTT<60).
- Age >18 years.
- The effects of DCs on the developing human fetus are unknown. For this reason, women
of child-bearing potential and men must agree to use adequate contraception (hormonal
or barrier method of birth control) prior to study entry and for the duration of study
participation. Should a woman become pregnant or suspect she is pregnant while
participating in this study, she should inform her treating physician immediately.
- No history of autoimmune diseases.
- Ability to understand the willingness to sign a written informed consent document.
Exclusion Criteria:- Patients may not be receiving anticoagulation therapy.
- Patients may not be receiving any other investigational agents.
- Patients with known brain metastases will be excluded because of their poor prognosis
and because they often develop progressive neurological dysfunction that would
confound the evaluation of neurological and other adverse effects.
- Uncontrolled concurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situation that would limit compliance with
- Patients with a history of portal hypertension, cirrhosis/hepatitis, or with
radiographic evidence of cirrhosis and/or varices are at high risk for developing a
complication when undergoing a liver biopsy and may be excluded at the investigators'
discretion from participation in this protocol.
- Patients who test positive for Hepatitis B virus, Hepatitis C virus or HIV.
biological: Intratumoral Dendritic Cell Immunotherapy
biological: autologous dendritic cells
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