Breast Cancer Clinical Trial

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

Summary

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.

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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

14

Study ID:

NCT00030823

Recruitment Status:

Completed

Sponsor:

Memorial Sloan Kettering Cancer Center

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There is 1 Location for this study

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Memorial Sloan-Kettering Cancer Center
New York New York, 10065, United States

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Study is for people with:

Breast Cancer

Estimated Enrollment:

14

Study ID:

NCT00030823

Recruitment Status:

Completed

Sponsor:


Memorial Sloan Kettering Cancer Center

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