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

Alternate Title

Phase I Study of Vaccination With Autologous Dendritic Cells Pulsed With Carcinoembryonic Antigen Peptide 1-6D (CAP 1-6D) and CMV pp65 Peptide in Patients With Refractory Stage IV CEA-Expressing Malignancies

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI	DUMC-4180-03-10R1 NCI-5910, NCT00057915, 5910

Trial Description

Purpose:

Vaccines made from a person's white blood cells mixed with peptides may make the body build an immune response to kill cancer cells.

This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with refractory stage IV cancer.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Measurable disease
• Must have received at least one standard chemotherapy regimen
• At least 4 weeks since biological therapy, chemotherapy, or radiation therapy
• 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' white blood cells will be collected and treated in the laboratory to make the vaccine. Patients will receive an injection of the vaccine every 3 weeks for a total of four or eight vaccinations. Patients will be evaluated every 3 months for 1 year.

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

Duke Comprehensive Cancer Center

Herbert Lyerly, MD, Protocol chair		Ph: 919-684-5613

Registry Information
Official Title		A Phase I Study of Active Immunotherapy with CAP-1 (6D) and CMVpp65 Peptide-Pulsed, Autologous Dendritic Cells Produced in the Aastromreplicell Cell Production System in Patients with Stage IV CEA Expressing Malignancies
Trial Start Date		2003-09-04
Registered in ClinicalTrials.gov		NCT00057915
Date Submitted to PDQ		2003-02-04
Information Last Verified		2006-09-13
NCI Grant/Contract Number		CA14236

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