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.
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.
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
New York New York, 10065, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.