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| Tracking Information | |||||
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| First Received Date ICMJE | June 10, 2004 | ||||
| Last Updated Date | July 11, 2009 | ||||
| Start Date ICMJE | April 2004 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Safety by CTC AE version 3.0 [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Safety by CTC AE version 3.0 | ||||
| Change History | Complete list of historical versions of study NCT00085241 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Vaccine Therapy and Radiation Therapy in Treating Patients With Carcinoembryonic Antigen-Positive Solid Tumors That Have Metastasized to the Liver | ||||
| Official Title ICMJE | A Pilot Trial Of A CEA-Tricom Based Vaccine And Radiation To Liver Metastasis In Adults With CEA Positive Solid Tumors | ||||
| Brief Summary | RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining vaccine therapy and radiation therapy may kill more tumor cells. PURPOSE: This clinical trial is studying how well giving vaccine therapy together with radiation therapy works in treating patients with carcinoembryonic antigen-positive solid tumors that have metastasized to the liver. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: Patients receive a priming vaccination of vaccinia (rV)-CEA-TRICOM and recombinant fowlpox GM-CSF (rF-GM-CSF) vaccine subcutaneously (SC) on day 1. Patients receive a booster vaccination of fowlpox (rF)-CEA-TRICOM and rF-GM-CSF SC on days 21, 35, 49, and 63. Patients undergo radiotherapy on days 22-25, 36-39, 50-53, and 64-67. Patients with stable disease or objective response after day 91 continue to receive rF-CEA-TRICOM and rF-GM-CSF SC every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed annually for 15 years. PROJECTED ACCRUAL: A total of 16 patients will be accrued for this study. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 16 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Immunological
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00085241 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000367490, NCI-04-C-0167, NCI-6368 | ||||
| Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | January 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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