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A Phase I Trial of Intratumoral Dendritic Cell Immunotherapy in Thermally Ablated Liver Metastases

Phase 1
18 Years
Not Enrolling
Liver Cancer

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Trial Information

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

- 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 institutional normal.

- 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
study requirements.

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the feasibility of harvesting autologous dendritic cells (DC) for CT-guided intratumoral DC injection

Outcome Time Frame:

NA- study terminated

Safety Issue:


Principal Investigator

Edgar G Engleman

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Food and Drug Administration

Study ID:




Start Date:

January 2004

Completion Date:

October 2007

Related Keywords:

  • Liver Cancer
  • Liver Neoplasms
  • Neoplasm Metastasis



Stanford University School of Medicine Stanford, California  94305-5317