A Pilot Trial of a CEA-TRICOM Based Vaccine and Radiation to Liver Metastasis in Adults With CEA Positive Solid Tumors
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).
Interventional
Primary Purpose: Treatment
United States: Federal Government
040167
NCT00081848
April 2004
August 2007
Name | Location |
---|---|
National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda, Maryland 20892 |