Phase I Intratumoral Dendritic Cell Immunotherapy in Thermally Ablated Liver Metastases

NCT00185874 | Terminated Phase 1

• 3 other identifiers: HEP0002NCT00185874NIH 16766
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (3)

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

  NA- study terminated

• 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.

  NA- study terminated

• To determine the toxicity of this regimen

  NA- study terminated

Secondary Outcomes (2)

• To determine the activity of this regimen as determined by tumor marker response, pathologic response and radiographic response of treated lesions.

  NA- study terminated

• To evaluate the immune response of patients treated with RFA + DC based on the presence and characterization of tumor infiltrating white blood cells

  NA- study terminated

Interventions

Intratumoral Dendritic Cell Immunotherapy BIOLOGICAL

autologous dendritic cells BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Edgar G Engleman

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: January 1, 2004
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: January 13, 2010

Record last verified: 2010-01

Locations

US (1)