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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA008748 | U.S. NIH Grant/Contract | View source | |
| MSKCC-06156 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccine Therapy and QS21 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QS21 | Biological |
| ||
| sialyl Lewisª-keyhole limpet hemocyanin conjugate vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | 2 years | |
| Immune Response | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Circulating Tumor Cells | 2 years |
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DISEASE CHARACTERISTICS:
Histologically confirmed stage IV breast cancer meeting 1 of the following criteria:
No evidence of disease
Stable disease on hormonal therapy
Hormone receptor status not specified
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Teresa Ann Gilewski, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety | Data were not collected | Posted | 2 years |
|
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular/Visual - Other (specify) | Eye disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction/extravasation | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Teresa Gilewski, MD | Memorial Sloan Kettering Cancer Center | (212) 639-2000 | gilewskt@mskcc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 24, 2018 | Oct 22, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D018567 | Breast Neoplasms, Male |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C078785 | saponin QA-21V1 |
| D007124 | Immunoenzyme Techniques |
| D007158 | Immunologic Techniques |
| ID | Term |
|---|---|
| D007118 | Immunoassay |
| D008919 | Investigative Techniques |
| D007150 | Immunohistochemistry |
| D015336 | Molecular Probe Techniques |
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| Biological |
|
| immunoenzyme technique | Other |
|
| immunologic technique | Other |
|
| laboratory biomarker analysis | Other |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| Primary | Immune Response | Data were not collected | Posted | 2 years |
|
|
| Secondary | Presence of Circulating Tumor Cells | Data were not collected | Posted | 2 years |
|
|
| 4 |
| 7 |
| 3 |
| 7 |
| 7 |
| 7 |
| Potassium, low (hypokalemia) | Metabolism and nutrition disorders | Systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Fatigue (asthenia, lethargy, malaise) | General disorders | Systematic Assessment |
|
| Albumin, low (hypoalbuminemia) | Metabolism and nutrition disorders | Systematic Assessment |
|
| Dermatology/Skin, other | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Glucose, high (hyperglycemia) | Metabolism and nutrition disorders | Systematic Assessment |
|
| Metabolic/Lab - Other (specify) | Metabolism and nutrition disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Pain - Head/headache | Nervous system disorders | Systematic Assessment |
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| Pain - Muscle | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Pain - Joint | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Edema: limb | General disorders | Systematic Assessment |
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| Fever (in the absence of neutropenia) | General disorders | Systematic Assessment |
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| Hair loss/alopecia (scalp or body) | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hemoglobin | Blood and lymphatic system disorders | Systematic Assessment |
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| Leukocytes (total WBC) | Blood and lymphatic system disorders | Systematic Assessment |
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| Mucositis (func/sympt)- Oral cavity | Gastrointestinal disorders | Systematic Assessment |
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| Ocular/Visual - Other (specify) | Eye disorders | Systematic Assessment |
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| Pruritus/itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rigors/chills | General disorders | Systematic Assessment |
|
| Sodium, high (hypernatremia) | Metabolism and nutrition disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |