Phase I Intratumoral Dendritic Cell Immunotherapy in Thermally Ablated Liver Metastases

This study has been terminated.
(Study closed due to lack of funding)
Sponsor:
Collaborator:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00185874
First received: September 12, 2005
Last updated: January 11, 2010
Last verified: January 2010
  Purpose

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 Intervention Phase
Liver Cancer
Biological: Intratumoral Dendritic Cell Immunotherapy
Biological: autologous dendritic cells
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Trial of Intratumoral Dendritic Cell Immunotherapy in Thermally Ablated Liver Metastases

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • To determine the feasibility of harvesting autologous dendritic cells (DC) for CT-guided intratumoral DC injection [ Time Frame: NA- study terminated ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To determine the toxicity of this regimen [ Time Frame: NA- study terminated ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 22
Study Start Date: January 2004
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185874

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Edgar G Engleman Stanford University
  More Information

No publications provided

Responsible Party: Edgar G Engleman, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00185874     History of Changes
Other Study ID Numbers: HEP0002, HEP0002, NIH 16766
Study First Received: September 12, 2005
Last Updated: January 11, 2010
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on September 22, 2014