Breast Cancer
Conditions
Keywords
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
Brief 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.
Detailed 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.
Interventions
BIOLOGICALGlobo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine
BIOLOGICALQS21
Sponsors
National Cancer Institute (NCI)
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 2 years | By assessing the toxicity and will be graded following immunization with polyvalent vaccine in accordance with the NCI Common Toxicity Criteria 2.0. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vaccine 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. | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Vaccine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 13 / 13 |
| serious Total, serious adverse events | 1 / 13 |
Outcome results
Primary
Safety
By assessing the toxicity and will be graded following immunization with polyvalent vaccine in accordance with the NCI Common Toxicity Criteria 2.0.
Time frame: 2 years
Population: All 13 participants experienced toxicities.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vaccine | Safety | 13 participants |