Vaccine Therapy in Treating Patients at High Risk for Breast Cancer Recurrence

Study Overview
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Brief Summary
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RATIONALE: Vaccines may make the body build an immune response and decrease the recurrence of breast cancer. PURPOSE: Pilot trial to study the effectiveness of vaccine therapy in treating patients who are at high risk for breast cancer recurrence.

Detailed Description
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OBJECTIVES: Determine whether immunization with multiple antigens comprising GM2, Globo-H, Lewis y, TF(c), sTn(c), Tn(c), and glycosylated MUC-1 32(aa) conjugated to keyhole limpet hemocyanin plus QS21 induces an antibody response against these individual antigens and breast cancer cells expressing these antigens in patients at high risk for breast cancer recurrence. Determine the toxic effects of this regimen in these patients. OUTLINE: Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 2-3 months.

Official Title
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Vaccination Of High Risk Breast Cancer Patients With Heptavalent Antigen - Keyhole Limpet Hemocyanin Conjugate Plus The Immunological Adjuvant QS21

Conditions
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Breast Cancer

Intervention / Treatment
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* Biological: Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine
* Biological: QS21


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of breast cancer at high risk for recurrence, defined by one of the following: Stage IV that is free of all known disease after eradication by surgery, radiotherapy, or chemotherapy May or may not have elevated CA 15-3 or CEA levels Stage I, II, or III previously treated with adjuvant chemotherapy and clinically free of identifiable disease, but have rising CA 15-3 or CEA levels Rising CA 15-3 and CEA defined as a prior normal level increased on 2 consecutive occasions at least 2 weeks apart For patients with a significant history of smoking who have a chronically elevated CEA (less than 15), CEA must be increased at least 1.5 times the uppermost chronic value on 2 consecutive occasions at least 2 weeks apart Stage III and completed adjuvant therapy no more than 24 months ago Recurrence in the ipsilateral axilla after lumpectomy and/or axillary dissection or modified radical mastectomy Recurrence in the ipsilateral breast after lumpectomy and/or axillary dissection Stage II with at least 4 positive axillary nodes and completed adjuvant therapy no more than 24 months ago Stage IV that is stable on hormonal therapy Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Male or female Menopausal status: Not specified Performance status: Karnofsky 80-100% Life expectancy: Not specified Hematopoietic: Lymphocyte count at least 500/mm^3 WBC at least 3,000/mm^3 Hepatic: AST no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 1.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No clinically significant New York Heart Association class III or IV cardiac disease Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No prior seafood allergy No known prior immunodeficiency or autoimmune disease No other active cancer except basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 weeks since prior immunotherapy No prior vaccine with any of the antigens in this study Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics At least 4 weeks since prior surgery Concurrent surgery for local recurrence allowed if patient remains disease free

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<br>Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19. | Biological: Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine<br> <br> Biological: QS21<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | By assessing the toxicity and will be graded following immunization with polyvalent vaccine in accordance with the NCI Common Toxicity Criteria 2.0. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I breast cancer, stage II breast cancer, stage IV breast cancer, stage IIIA breast cancer, recurrent breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, male breast cancer