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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Related Information
Registry Information

Alternate Title

Pilot Study of Vaccinia-CEA-TRICOM Vaccine, Fowlpox-CEA-TRICOM Vaccine, Recombinant Fowlpox GM-CSF Vaccine, and Radiotherapy in Patients With Carcinoembryonic Antigen-Positive Solid Tumors Metastatic to the Liver

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Treatment	Closed	18 and over	NCI	NCI-04-C-0167 6368, NCI-6368, NCT00085241

Trial Description

Purpose:

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.

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.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No brain metastases
• More than 3 weeks since chemotherapy
• At least 2 weeks since steroid eye drops
• No previous radiation therapy to the entire liver
• No previous surgery to remove the spleen
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will receive injections of two vaccines on day 1. They will receive two booster vaccinations in weeks 3, 5, 7, and 9. Patients will also undergo radiation therapy 4 days a week in weeks 4, 6, 8, and 10. Beginning in week 14, some patients may continue to receive the vaccines every 4 weeks for as long as benefit is shown.

Patients will be evaluated once a year for 15 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

James Gulley, MD, PhD, FACP, Principal investigator		Ph: 301-435-2956 Email: gulleyj@mail.nih.gov

Related Information

Web site for additional information

Registry Information
Official Title		A Pilot Trial Of A CEA-Tricom Based Vaccine And Radiation To Liver Metastasis In Adults With CEA Positive Solid Tumors
Trial Start Date		2004-04-22
Registered in ClinicalTrials.gov		NCT00085241
Date Submitted to PDQ		2004-04-21
Information Last Verified		2007-01-07

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