Breast Cancer
Conditions
Keywords
recurrent breast cancer, stage IV breast cancer, male breast cancer
Brief summary
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
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | 2 years |
| Immune Response | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Presence of Circulating Tumor Cells | 2 years |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vaccine Therapy and QS21 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 | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Vaccine Therapy and QS21 |
|---|---|
| Age, Continuous | 44 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 7 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 7 |
| other Total, other adverse events | 7 / 7 |
| serious Total, serious adverse events | 3 / 7 |
Outcome results
Immune Response
Time frame: 2 years
Population: Data were not collected
Safety
Time frame: 2 years
Population: Data were not collected
Presence of Circulating Tumor Cells
Time frame: 2 years
Population: Data were not collected