An interventional study of QS21 and sialyl Lewisª-keyhole limpet hemocyanin conjugate vaccine in Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2020-11-18.
Sponsored by Memorial Sloan Kettering Cancer Center · Not applicable, Interventional, and Treatment
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.
OBJECTIVES:
Primary
Secondary
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 7 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.
Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.
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DISEASE CHARACTERISTICS:
Histologically confirmed stage IV breast cancer meeting 1 of the following criteria:
Stable disease on hormonal therapy
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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
Biological: QS21 · Biological: sialyl Lewisª-keyhole limpet hemocyanin conjugate vaccine · Other: immunoenzyme technique · Other: immunologic technique · Other: laboratory biomarker analysis
Safety
Time frame: 2 years
Immune Response
Time frame: 2 years
Presence of Circulating Tumor Cells
Time frame: 2 years
| Milestone | Vaccine Therapy and QS21 |
|---|---|
| Started | 7 |
| Completed | 7 |
| Not completed | 0 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Collected over 2 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vaccine Therapy and QS21 | 4/7 (57.1%) | 3/7 (42.9%) | 7/7 (100%) |
| Event | Vaccine Therapy and QS21 |
|---|---|
| Ocular/Visual - Other (specify)Eye disorders | 1/7 |
| Potassium, low (hypokalemia)Metabolism and nutrition disorders | 1/7 |
| Rash/desquamationSkin and subcutaneous tissue disorders | 1/7 |
| Event | Vaccine Therapy and QS21 |
|---|---|
| Injection site reaction/extravasationGeneral disorders | 7/7 |
| Fatigue (asthenia, lethargy, malaise)General disorders | 4/7 |
| Albumin, low (hypoalbuminemia)Metabolism and nutrition disorders | 3/7 |
| Dermatology/Skin, otherSkin and subcutaneous tissue disorders | 3/7 |
| Glucose, high (hyperglycemia)Metabolism and nutrition disorders | 3/7 |
| Metabolic/Lab - Other (specify)Metabolism and nutrition disorders | 3/7 |
| NauseaGastrointestinal disorders | 3/7 |
| Pain - Head/headacheNervous system disorders | 3/7 |
| Pain - MuscleMusculoskeletal and connective tissue disorders | 3/7 |
| DiarrheaGastrointestinal disorders | 2/7 |
| Age, Continuous(years) | Vaccine Therapy and QS21 |
|---|---|
| Median | 44 (31 to 65) |
| Sex: Female, Male(Participants) | Vaccine Therapy and QS21 |
|---|---|
| Female | 7 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Vaccine Therapy and QS21 |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 6 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Vaccine Therapy and QS21 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 6 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Vaccine Therapy and QS21 |
|---|---|
| United States | 7 |
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Memorial Sloan Kettering Cancer Center