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| ID | Type | Description | Link |
|---|---|---|---|
| P50CA058223 | U.S. NIH Grant/Contract | View source | |
| R21CA105837 | U.S. NIH Grant/Contract | View source | |
| KG100307 | Other Grant/Funding Number | Susan G Komen for the Cure |
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Funding unavailable
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Susan G. Komen Breast Cancer Foundation | OTHER |
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RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with monoclonal antibody therapy and chemotherapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving vaccine therapy together with trastuzumab and vinorelbine works in treating women with locally recurrent or metastatic breast cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE:
Note: *If treatment is given locally, the vaccine therapy will be given at University of North Carolina (UNC) -Chapel Hill the following day.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 17-37 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dendritic Cell Vaccine | Experimental | Dendritic Cells: Dosage: 20 x 106 dendritic cells (DCs) given per treatment Vinorelbine:25 mg/m2 will be administered i.v biweekly Trastuzumab: 6mg/Kg administered by i.v. biweekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| therapeutic autologous dendritic cells | Biological | 10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with GM-CSF 250 μg/m2 sc each day for four days. G-CSF and/or GM- CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and then undergo a 15 litre apheresis collection |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | Response measured by Response Evaluation Criteria In Solid Tumors (RECIST), (Complete Response + Partial Response) Complete Response (CR)- Disappearance of all target lesions Partial Response (PR)-at least a 30% decrease in the longest diameters of target lesions, taking as reference the baseline longest diameter. | 6 months following treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Immune Response | Measured by intracellular cytokine staining for Interferon-gamma (INFgamma) and cluster of differentiation (CD107) up regulation and tetramer. A fourfold increase in the number of cluster of differentiation (CD8+) tetramers comparing prevaccine with peak postvaccine values indicated an immune response to the therapy. | 3 months following treatment |
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DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
HLA-A0201 positive by DNA genotyping
HER2/neu expression at least 1+ by immunohistochemistry of tumor sample
Central Nervous System (CNS) metastases allowed provided on therapy for 3 months and stable
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan S. Serody, MD | UNC Lineberger Comprehensive Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599-7295 | United States |
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| Label | URL |
|---|---|
| UNC Lineberger Comprehensive Cancer Center | View source |
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56 patients enrolled; 23 were human leukocyte antigen (HLA:A2) negative, 11 withdrew/refused treatment prior to start, 4 consented/not treated due to study closure, 3 went to a different study, 2 died before treatment, 2 were human epidermal growth factor receptor 2 (HER-2/neu) not detectable, and 4 patients ineligible. 7 patients were evaluable.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dendritic Cell Vaccine | Dendritic Cells (DCs): Dosage: 20 x 106 DCs given per treatment Vinorelbine:25 mg/m2 will be administered i.v biweekly Trastuzumab: 6mg/Kg administered by i.v. biweekly therapeutic autologous dendritic cells: 10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with Granulocyte-macrophage colony-stimulating factor (GM-CSF) 250 μg/m2 sc each day for four days. G-CSF and/or GM-CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and then undergo a 15 litre apheresis collection trastuzumab: 4 mg/kg intravenously, every 14 days vinorelbine ditartrate: Vinorelbine 25 mg/m2 will be administered intravenously, every 14 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| trastuzumab | Biological | 4 mg/kg intravenously, every 14 days |
|
| vinorelbine ditartrate | Drug | Vinorelbine 25 mg/m2 will be administered intravenously, every 14 days |
|
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dendritic Cell Vaccine | Dendritic Cells: Dosage: 20 x 106 DCs given per treatment Vinorelbine:25 mg/m2 will be administered i.v biweekly Trastuzumab: 6mg/Kg administered by i.v. biweekly therapeutic autologous dendritic cells: 10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with GM-CSF 250 μg/m2 sc each day for four days. G-CSF and/or GM- CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and then undergo a 15 litre apheresis collection trastuzumab: 4 mg/kg intravenously, every 14 days vinorelbine ditartrate: Vinorelbine 25 mg/m2 will be administered intravenously, every 14 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | 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 |
|
| 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 | Overall Response Rate | Response measured by Response Evaluation Criteria In Solid Tumors (RECIST), (Complete Response + Partial Response) Complete Response (CR)- Disappearance of all target lesions Partial Response (PR)-at least a 30% decrease in the longest diameters of target lesions, taking as reference the baseline longest diameter. | Posted | Count of Participants | Participants | 6 months following treatment |
|
|
| |||||||||||||||||||||||||||
| Secondary | Immune Response | Measured by intracellular cytokine staining for Interferon-gamma (INFgamma) and cluster of differentiation (CD107) up regulation and tetramer. A fourfold increase in the number of cluster of differentiation (CD8+) tetramers comparing prevaccine with peak postvaccine values indicated an immune response to the therapy. | Posted | Count of Participants | Participants | 3 months following treatment |
|
|
Toxicity was assessed on day 14 of each cycle and again 15-30 days post treatment.
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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 | Dendritic Cell Vaccine | Dendritic Cells: Dosage: 20 x 106 DCs given per treatment Vinorelbine:25 mg/m2 will be administered i.v biweekly Trastuzumab: 6mg/Kg administered by i.v. biweekly therapeutic autologous dendritic cells: 10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with GM-CSF 250 μg/m2 sc each day for four days. G-CSF and/or GM- CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and then undergo a 15 litre apheresis collection trastuzumab: 4 mg/kg intravenously, every 14 days vinorelbine ditartrate: Vinorelbine 25 mg/m2 will be administered intravenously, every 14 days | 6 | 7 | 3 | 7 | 6 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bone Pain | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Dyspepsia/heartburn | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Edema | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Fatigue (lethargy, malaise, asthenia) | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L) | General disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Leukocytes (total WBC) | Investigations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Neuropathy-sensory | Nervous system disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Investigations | CTCAE (2.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Non-systematic Assessment |
| |
| Pain - Other (Specify) | General disorders | CTCAE (2.0) | Non-systematic Assessment | wrist pain |
|
| Platelets | Investigations | CTCAE (2.0) | Non-systematic Assessment |
|
Study was terminated due to unavailable funding.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robin V. Johnson | UNC Lineberger Comprehensive Cancer Center | 919-966-1125 | Robin_V_Johnson@UNC.med.edu |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| D000077235 | Vinorelbine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|