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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 Replication-Incompetent Ad-sig-hMUC-1/ecdCD40L Vaccine in Women With Previously Treated Metastatic Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Active	Over 18	NCI	UCLA-07-05-056 07-05-056, NCT00706615

Trial Description

Purpose:

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

This phase I trial is studying the side effects and best dose of vaccine therapy in treating women with previously treated metastatic breast cancer.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No previous organ transplant or donor bone marrow transplant
• At least 4 weeks since surgery and/or radiation therapy
• At least 1 month since tamoxifen, doxorubicin, lapatinib, trastuzumab, or bevacizumab
• 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 an injection of the vaccine.

After finishing treatment, patients will be evaluated once a month for 9 months.

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

Jonsson Comprehensive Cancer Center at UCLA

Sara Hurvitz, MD, Principal investigator		Ph: 310-829-5471; 888-798-0719

U.S.A.
California
	Los Angeles
	Jonsson Comprehensive Cancer Center at UCLA
		Clinical Trials Office - Jonsson Comprehensive Cancer Center at UCLA	Ph:  888-798-0719

Registry Information
Official Title		A Single Arm Open-Label Phase I Study of An Injectable Replication-Incompetent Adenoviral Vector Vaccine Used to Produce An Immune Response to MUC-1 Positive Epithelial Cancer Cells in Metastatic Breast Cancer
Trial Start Date		2008-05-20
Trial Completion Date		2009-06-23 (estimated)
Registered in ClinicalTrials.gov		NCT00706615
Date Submitted to PDQ		2008-06-19
Information Last Verified		2008-12-21
NCI Grant/Contract Number		CA16042