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This is a pilot protocol to evaluate the safety, feasibility, and immunogenicity of a personalized breast cancer vaccine based utilizing whole exome sequencing data of a patient's residual breast tumor following neoadjuvant chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dendritic Cell (DC) Vaccine | Experimental | The tumor specimen collected from the primary tumor will undergo whole exome sequencing (WES). The WES data will be analyzed to select up to 20 neoantigens. From this screen up to 10 peptides will be selected to be synthesized for testing and use on the DC pheresis product that will be collected. The ready vaccine product will be cryopreserved and then thawed once the patient is ready to under the vaccination sequence. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leukapheresis | Procedure | Removal of white blood cells (leukocytes) from the blood. The dendritic cells are harvested from the white blood cells that are collected and trained to recognize the specific abnormal proteins found in the tumor sample. One needle is inserted in each arm. An apheresis machine removes blood from the vein in one arm, separates and retains the leukocytes from the blood, and then returns the rest of the blood to the other arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients enrolled who successfully undergo at least one vaccination. | Successful production and administration of DC1 priming vaccination sequence in greater than 60% of patients enrolled. | Up to 3 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who achieve Immunogenicity after administration of vaccine | Immunogenicity will be determined by ELISpot and reactive T-Cell Receptor (TCR) expansion. ELISPot is an enzyme-linked immunospot assay. It is a highly sensitive immunoassay that measures the frequency of cytokine-secreting cells at the single-cell level. | Up to 3 Years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Neveen Abdo | Contact | 813-745-4412 | neveen.abdo@moffitt.org |
| Name | Affiliation | Role |
|---|---|---|
| Hatem Soliman, MD | Moffitt Cancer Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
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| Label | URL |
|---|---|
| Moffitt Cancer Center Clinical Trials Website | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D007937 | Leukapheresis |
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D016238 | Cytapheresis |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D001781 | Blood Component Removal |
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| Dendritic Cell (DC) Vaccine | Biological | The vaccine will be given intranodally (inguinal or axillary) under ultrasound guidance using a dose of 40-50 million cells three times spaced 2 weeks apart for the initial priming sequence. 3 doses of the priming vaccines are given once every 2 weeks. 2 booster shots (if available) will be given 6 months and 12 months following completion of initial priming vaccines. |
|
| Disease Free Survival (DFS) | Disease Free Survival will be measured as the length of time after treatment to cancer recurrence or death from any cause. | Up to 3 Years |
| D017437 |
| Skin and Connective Tissue Diseases |
| D047589 |
| Leukocyte Reduction Procedures |
| D002469 | Cell Separation |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D008919 | Investigative Techniques |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |