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Sponsors and Collaborators: |
Stanford University National Institutes of Health (NIH) |
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Information provided by: | Stanford University |
ClinicalTrials.gov Identifier: | 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.
Condition | Intervention | Phase |
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Liver Cancer |
Biological: Intratumoral Dendritic Cell Immunotherapy Biological: autologous dendritic cells |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Trial of Intratumoral Dendritic Cell Immunotherapy in Thermally Ablated Liver Metastases |
Estimated Enrollment: | 22 |
Study Start Date: | January 2004 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
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:
Patients must have normal organ and marrow functions as defined below:
United States, California | |
Stanford University School of Medicine | |
Stanford, California, United States, 94305 |
Principal Investigator: | Edgar G Engleman | Stanford University |
Study ID Numbers: | HEP0002, HEP0002, NCT00185874, NIH 16766 |
Study First Received: | September 12, 2005 |
Last Updated: | July 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00185874 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Liver Neoplasms Liver Diseases Digestive System Diseases Digestive System Neoplasms |
Liver neoplasms Neoplasm Metastasis Gastrointestinal Neoplasms |
Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Site |