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NCT00081848 · ClinicalTrials.gov registry record · Phase 1
Vaccine Therapy and Radiation to Liver Metastasis in Patients With CEA-Positive Solid Tumors
A Phase 1 study of Liver Neoplasms, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT00081848: Completed Phase 1 study of Liver Neoplasms, sponsored by National Cancer Institute (NCI).
NCT00081848 is a Phase 1 study of Liver Neoplasms that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 12 participants, below the 464-participant average among 14 other Liver Neoplasms trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00081848, a Phase 1 study of Liver Neoplasms, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate the safety and effects of vaccine treatment plus radiation to the liver in patients with solid tumors that have spread to the liver. The vaccine treatment consists of three parts: 1) a "priming vaccine" called rV-CEA(6D)-TRICOM, made from vaccinia virus; 2) a "boosting vaccine" called rF-CEA(6D)-TRICOM), made from fowlpox virus; and 3) a fowlpox virus injected with DNA for GM-CSF, a chemical that boosts the immune system, called rF-GM-CSF. Human DNA is inserted into the priming and boosting vaccine viruses to cause production of proteins that enhance immune activity and also to produce carcinoembryonic antigen (CEA) - a protein that is normally produced by the patient's tumor cells. The study also uses radiation, because laboratory and animal studies show that low doses of radiation to tumors that produce CEA make the tumor more sensitive to the effects of the vaccines. Patients 18 years of age and older who have a solid tumor that has spread to the liver may be eligible for this study. Candidates must have had at least one course of chemotherapy for metastatic disease and their tumor must produce CEA. Candidates are screened with a medical history and physical examination; blood and urine tests, test of pathology slides from surgery to determine the presence of the CEA marker, imaging studies to assess the extent of tumor, and an electrocardiogram (and cardiologic evaluation, if clinically indicated). Participants receive the priming vaccination on study day 1. After 3 weeks and then again every 2 weeks for 2 months (study days 21, 35, 49 and 63), they receive a boosting vaccine. All vaccines are injected under the skin. With every vaccination they also receive an injection of rF-GM-CSF to increase the number of immune cells at the vaccination site. The day after each of the first four boosting vaccinations, patients undergo 4 consecutive days of radiation to the tumor in the liver (study days 22-25, 36-39, 50-53 and 64-67). Patients may
Conditions Studied
Interventions
- DRUG Celecoxib
- DRUG rV-CEA(6D)/TRICOM-rF-CEA(6D)/TRICOM
- DRUG rF-CEA(6D)/TRICOM
- DRUG Recombinant Fowlpox-GM-CSF
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2004-04-20 |
| Est. Completion | 2007-08-23 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00081848
The ClinicalTrials.gov registry entry for NCT00081848 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 464-participant average among 14 other Liver Neoplasms trials with a reported enrollment target (97% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Liver Neoplasms appearing as the primary indexed condition, and to 4 interventions - of which Celecoxib is the first listed.
NCT00081848 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00081848 about?
NCT00081848 is a clinical study titled "Vaccine Therapy and Radiation to Liver Metastasis in Patients With CEA-Positive Solid Tumors". This study will evaluate the safety and effects of vaccine treatment plus radiation to the liver in patients with solid tumors that have spread to the liver. The vaccine treatment consists of three parts: 1) a "priming vaccine" called rV-CEA(6D)-TRICOM, made from vaccinia virus; 2) a "boosting vacci...
What is the current status of trial NCT00081848?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2004-04-20. Estimated completion is 2007-08-23.
What conditions does trial NCT00081848 study?
This clinical trial studies the following conditions: Liver Neoplasms.
What interventions are being tested in trial NCT00081848?
The interventions under investigation include: Celecoxib (DRUG), rV-CEA(6D)/TRICOM-rF-CEA(6D)/TRICOM (DRUG), rF-CEA(6D)/TRICOM (DRUG), Recombinant Fowlpox-GM-CSF (DRUG).
Who is sponsoring clinical trial NCT00081848?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00081848 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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