Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Cancer Institute (NCI)
Background: * A phase I clinical trial with this same vaccine alone was associated with stable disease (at least 4 months) in 40% of patients and 1 pathologic complete response. * Radiation therapy upregulates Fas on tumor cells allowing for easier killing by antigen specific activated T cells. Dominant negative fas transfected tumor cells demonstrated the anti-tumor effects were fas mediated. * Radiation has been shown to up-regulate ICAM, tumor associated antigens and MHC class I on human tumor cell lines in vitro. * TRICOM vaccines act synergistically with radiation in tumor treatment models. * Radiation therapy at the doses we propose appears to have a favorable safety profile. * Clinical trials using PSA vaccine shows that local radiation of tumor does not inhibit vaccine efficacy. Objectives: * 1: Safety of the combination of a CEA based vaccine and radiation * 2: clinical response * 2: Immunohistochemistry - (FAS, MHC, p53 and CEA on tumor before and after radiation therapy) * 2: Immunological response (ELISPOT assay). Eligibility: * Solid Tumors expressing CEA positive cancer with radiographically visible metastatic liver lesions. * Completed at least one chemotherapy regimen for metastatic disease. * Life expectancy greater than or equal to 6 months * Adequate organ function * ECOG 0-1 * No autoimmunity * No serum positivity for HIV, Hepatitis B or C viruses Design: * Single cohort pilot study of vaccine and radiation therapy to liver lesions in 10 evaluable patients. All vaccines and radiation are given at the NIH Clinical Center. * Vaccine: rV-CEA(6D)/TRICOM, (1.2 x 10(8)) PFU subcutaneously (s.c.) day 1 rF-CEA(6D)/TRICOM, (4 x 10(8)) PFU s.c., days 21, 35, 49, and 63 All vaccinations will be given with rF-GM-CSF, 1 x 10(7) pfu s.c. -Radiation: 2 Gy/d for 4 days after each dose of rF-CEA(6D)/TRICOM on days 22-25, 36-39, 50-53, and 64-67 (total planned radiation dose per patient is 32 Gy).
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
