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| Name | Class |
|---|---|
| Ontario Cancer Research Network | NETWORK |
| Canadian Breast Cancer Research Alliance | OTHER |
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The purpose of this study is to determine the maximum tolerated dose and/or maximum attainable dose of a vaccine consisting of human autologous dendritic cells transduced by an adenovector expressing rat Her-2/neu (AdHer-2/neu) in patients with metastatic breast cancer.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AdHer-2/neu transduced dendritic cells | Biological | Group 1 1 ×10'7 expanded cells (2.5 ×106 DCs per injection site) Group 2 5 ×10'7 expanded cells (1.25 ×107 DCs per injection site) Group 3 1 ×10'8 expanded cells (2.5 ×107 DCs per injection site) |
| Measure | Description | Time Frame |
|---|---|---|
| toxicity | weeks 4, 6, 7, 10, 14, 18, 22, 26 |
| Measure | Description | Time Frame |
|---|---|---|
| tumour response | Weeks 6, 18 |
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Inclusion Criteria:
Metastatic or locally recurrent breast cancer
18 years of age or older
Her-2/neu positive (3+ by immunohistochemistry or fluorescence in-situ hybridization [FISH] +)
One of the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sukhbinder Dhesy-Thind, M.D. | Ontario Clinical Oncology Group; Juravinski Cancer Centre - Hamilton Health Sciences; McMaster University | Study Chair |
| Ronan Foley, M.D. | McMaster University | Principal Investigator |
| Richard Tozer, M.D. | Juravinski Cancer Centre - Hamilton Health Sciences | Principal Investigator |
| Peter Ellis, M.D. | Juravinski Cancer Centre - Hamilton Health Sciences | Principal Investigator |
| Jack Gauldie, M.D. | McMaster University | Principal Investigator |
| Mark Levine, M.D. | Ontario Clinical Oncology Group (OCOG) | Principal Investigator |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| D017437 |
| Skin and Connective Tissue Diseases |