Vaccine Therapy in Treating Women With Previously Treated Metastatic Breast Cancer

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

NCT00706615•Jonsson Comprehensive Cancer Center

View on ClinicalTrials.gov

Summary

RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating women with previously treated metastatic breast cancer.

Detailed Description

OBJECTIVES: Primary * Characterize the safety profile of Ad-sig-hMUC-1/ecdCD40L vaccine in women with metastatic breast cancer. * Identify a tolerable, immunologically active dose level of this vaccine in these patients. Secondary * Evaluate the immune function in these patients before and after treatment with this vaccine. OUTLINE: Patients receive MUC-1 vector vaccine subcutaneously on day 0. After completion of study treatment, patients are followed monthly for 9 months.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Women over the age of 18 with metastatic or non-measureable adenocarcinoma of the breast with marrow involvement.
•Elevated serum MUC-1 levels, as measured by CA 15-3 or CA 27-29
•Stable disease (defined as fluctuation of \<50U in CA15-3 or CA27-29 value) for at least 3 months while either on no breast-cancer therapy or while on current therapy (Tamoxifen, fulvestrant, exemestane, letrozole, anastrozole, bisphosphonates or trastuzumab chemotherapy is not allowed)
•ability to understand the risks, benefits, and procedures and provide written informed consent.
•less than 28 days prior to enrollment since last surgery and/or radiation therapy.
•performance status \<=2 on the ECOG performance scale and life expectancy of greater than 12 months
•NYHA cardiac function Class I or Class II and normal baseline ECG. If ECG is abnormal, patient must have an echocardiogram showing a left ventricular ejection fraction greater than the lower limits of normal.
•Acceptable pulmonary function. if questionable, a pulmonary function test will be performed.
•negative serology for hepatitis B, C and HIV.
•red cell mean corpuscular volume \>- 80 cu. mm, hemoglobin \>- 8g/dl, platelet count \>- 100,000/dl: AST, ALT, LDH \<-2 times the Upper limit of normal
+2 more criteria

Exclusion Criteria

•history of bronchospasm or asthma requiring inhaled or oral steroid treatment
•Normal MUC-1 (CA 15-3 or CA 27-29)
•treatment with steroid or other immunosuppressive medication (for any condition ) within 30 days of trial registration.
•history of any autoimmune disease (e.g., lupus, rheumatoid arthritis, or psoriasis)
•uncontrolled diabetes mellitus
•unable or unwilling to undergo repeated clinical evaluations and other diagnostic procedures or unable to sign an informed consent.
•history of other malignancies, except squamous cell or basal cell carcinoma of the skin or cervical carcinoma in situ.
•Concurrent systemic chemotherapy (tamoxifen, aromatase inhibitors, fulvestrant, trastuzumab and biophosphonates are allowed if started more than 3 months prior to trial registration with evidence of stable disease as defined above. Chemotherapy must have stopped 3 months prior to enrolling in this trial).
•history of ornithine transcarbamylase deficiency
•any acute or chronic viral, bacterial, or fungal infection requiring specific therapy, unless acute therapy was completed within the past 14 days
+4 more criteria

Locations (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, United States

Key Dates

Start Date

July 1, 2008

Primary Completion Date

April 1, 2009

Last Updated

July 31, 2020

Conditions

Breast Cancer

Interventions

Ad-sig-hMUC-1/ecdCD40L vaccine

BIOLOGICAL

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 31, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Vaccine Therapy in Treating Women With Previously Treated Metastatic Breast Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer