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

Alternate Title

Phase II Randomized Study of Immunization With Carcinoembryonic Antigen (CEA) Peptide 1-6D Emulsified in Montanide ISA-51 Versus Dissolved in Sargramostim (GM-CSF) in HLA-A2+ Patients With CEA-Producing Adenocarcinomas of Gastrointestinal Tract Origin

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	UTMB-00-297 NCI-931, NCT00012246, 931

Trial Description

Purpose:

Vaccines may make the body build an immune response to kill tumor cells.

Randomized phase II trial to compare the effectiveness of two different vaccines in treating patients who have cancer of the gastrointestinal tract.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• At least 4 weeks since biological therapy, chemotherapy, radiation therapy, or surgery
• 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 be randomly assigned to one of two groups. Patients in group one will receive an injection of the vaccine every 3 weeks for up to six courses. Patients in group two will receive another vaccine every 3 weeks for up to six courses. Patients will be evaluated at 3 weeks and periodically thereafter.

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

University of Texas Medical Branch

Robert Whitehead, MD, Protocol chair(Contact information may not be current)		Ph: 409-772-2981

Registry Information
Official Title		A Trial Of Vaccination With The Carcinoembryonic Antigen (CEA) Peptide Cap 1-6D With Montanide ISA 51 Adjuvant Or Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) In HLA-A2+ Patients With CEA Producing Adenocarcinomas Of Gastrointestinal (GI) Tract Origin
Trial Start Date		2002-07-22
Registered in ClinicalTrials.gov		NCT00012246
Date Submitted to PDQ		2001-01-16
Information Last Verified		2006-01-10

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