Vaccine Therapy and QS21 in Treating Patients With Metastatic Breast Cancer

Study Overview
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Brief Summary
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RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy together with QS21 may cause a stronger immune response and kill more tumor cells. PURPOSE: This clinical trial is studying the side effects and how well giving vaccine therapy together with QS21 works in treating patients with metastatic breast cancer.

Detailed Description
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OBJECTIVES: Primary Determine the safety of sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine and QS21 immunoadjuvant in patients with metastatic breast cancer. Determine the IgG and IgM antibody response to this regimen in these patients. Determine the proportion of breast cancer cells expressing this antigen in these patients. Secondary Monitor the presence of circulating tumor cells prior to, during, and after this regimen in these patients. OUTLINE: Patients receive sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine subcutaneously (SC) and QS21 immunoadjuvant SC once in weeks 1, 2, 3, 7, and 19 in the absence of disease progression or unacceptable disease. Blood samples are collected periodically and evaluated for circulating tumor cells and reactivity against sialyl Lewisª antigen in ELISA and/or immunoprecipitation-western blot assays. After completion of study treatment, patients are followed every 3 months.

Official Title
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Pilot Study of Immunization of High Risk Breast Cancer Patients With a Sialyl Lewisª -Keyhole Limpet Hemocyanin Conjugate Plus the Immunological Adjuvant QS-21

Conditions
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Breast Cancer

Intervention / Treatment
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* Biological: QS21
* Biological: sialyl Lewisª-keyhole limpet hemocyanin conjugate vaccine
* Other: immunoenzyme technique
* Other: immunologic technique
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed stage IV breast cancer meeting 1 of the following criteria: No evidence of disease Stable disease on hormonal therapy Stable disease must be present for ≥ 2 months and include < 30% decrease or < 20% increase in the sum of the longest diameter of target lesion No new target lesions or unequivocal progression of non-target lesions Elevation in the CA 153 (BR2729) or CEA values allowed Hormone receptor status not specified PATIENT CHARACTERISTICS: Female or male Menopausal status not specified Karnofsky performance status 80-100% Lymphocyte count ≥ 500/mm³ WBC ≥ 3,000/mm³ Creatinine ≤ 1.5 times upper limit of normal (ULN) AST ≤ 1.5 times ULN Alkaline phosphatase ≤ 1.5 times ULN Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No history of allergy to seafood No NYHA class III-IV cardiac disease No other active cancers except basal cell or squamous cell carcinoma of the skin No active infection requiring antibiotic treatment No known history of immunodeficiency or autoimmune disease PRIOR CONCURRENT THERAPY: See Disease Characteristics At least 4 weeks since prior chemotherapy At least 4 weeks since prior radiotherapy At least 4 weeks since prior surgery At least 6 weeks since prior immunotherapy No prior sialyl Lewisª antigen No concurrent immunosuppressive medications (i.e., corticosteroids) Concurrent hormonal therapy allowed

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaccine Therapy and QS21<br>Patients receive sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine subcutaneously (SC) and QS21 immunoadjuvant SC once in weeks 1, 2, 3, 7, and 19 in the absence of disease progression or unacceptable disease. Blood samples are collected periodically and evaluated for circulating tumor cells and reactivity against sialyl Lewisª antigen in ELISA and/or immunoprecipitation-western blot assays. After completion of study treatment, patients are followed every 3 months | Biological: QS21<br> <br> Biological: sialyl Lewisª-keyhole limpet hemocyanin conjugate vaccine<br> <br> Other: immunoenzyme technique<br> <br> Other: immunologic technique<br> <br> Other: laboratory biomarker analysis<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | 2 years | 
| Immune Response |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Circulating Tumor Cells |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent breast cancer, stage IV breast cancer, male breast cancer