COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Phase I Intratumoral Dendritic Cell Immunotherapy in Thermally Ablated Liver Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00185874
Recruitment Status : Terminated (Study closed due to lack of funding)
First Posted : September 16, 2005
Last Update Posted : January 13, 2010
National Institutes of Health (NIH)
Information provided by:
Stanford University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Liver Cancer Biological: Intratumoral Dendritic Cell Immunotherapy Biological: autologous dendritic cells Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Trial of Intratumoral Dendritic Cell Immunotherapy in Thermally Ablated Liver Metastases
Study Start Date : January 2004
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. To determine the feasibility of harvesting autologous dendritic cells (DC) for CT-guided intratumoral DC injection [ Time Frame: NA- study terminated ]
  2. To establish the maximally tolerated dose (MTD) and dose limiting toxicity (DLT) of intratumoral autologous dendritic cell vaccination in combination with radiofrequency ablation (RFA) of liver metastases. [ Time Frame: NA- study terminated ]
  3. To determine the toxicity of this regimen [ Time Frame: NA- study terminated ]

Secondary Outcome Measures :
  1. To determine the activity of this regimen as determined by tumor marker response, pathologic response and radiographic response of treated lesions. [ Time Frame: NA- study terminated ]
  2. To evaluate the immune response of patients treated with RFA + DC based on the presence and characterization of tumor infiltrating white blood cells [ Time Frame: NA- study terminated ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00185874

Layout table for location information
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Institutes of Health (NIH)
Layout table for investigator information
Principal Investigator: Edgar G Engleman Stanford University
Layout table for additonal information
Responsible Party: Edgar G Engleman, Stanford University School of Medicine Identifier: NCT00185874    
Other Study ID Numbers: HEP0002
NIH 16766
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: January 13, 2010
Last Verified: January 2010
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases