A Phase 1/2 interventional study of Dendritic Cell/Tumor Fusion Vaccine and Interleukin-12 in Breast Cancer, sponsored by Beth Israel Deaconess Medical Center. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-14.
Sponsored by Beth Israel Deaconess Medical Center · Phase 1/2, Interventional, and Treatment
The purpose of this study is to test the safety of an investigational Dendritic Cell/Tumor Fusion vaccine given with IL-12 for patients with breast cancer.
RATIONALE: Vaccines made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells. Interleukin-12 may stimulate the white blood cells to kill tumor cells. Giving vaccine therapy together with interleukin-12 may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of interleukin-12 when given together with vaccine therapy and to see how well they work in treating women with stage IV breast cancer.
TUMOR COLLECTION: Tumor cells will be collected from the participant to make the study vaccine. Based on the location of the tumor, a decision will be made as to the best approach to obtain these cells.
DENDRITIC CELL COLLECTION: Participants will undergo a procedure known as leukapheresis to obtain their dendritic cells (this procedure may be done before or after the tumor cells have been obtained). This procedure takes about 2-4 hours. If not enough cells are collected, the participant may be asked to return for an additional leukapheresis procedure. If sufficient number of cells are obtained, tumor cells and dendritic cells will then be fused (combined together to make one larger cell) together in the laboratory and divided into the appropriate dose for administration.
TREATMENT: Treatment will consist of an injection of tumor cells fused with dendritic cells under the skin every 3 weeks for a total of 9 weeks. The dose that the participant receives will depend on the total number of fusion cells that are made.
STUDY COHORTS: The first group of three participants will receive the DC/Tumor Fusion study vaccine alone. The next group of 3 participants will receive the DC/Tumor Fusion study vaccine with a low dose of Il-12. If there are no significant side effects the following groups of subjects will be treated with the DC/Tumor Fusion study vaccine and a higher dose of Il-12.
PATIENT MONITORING: Participants will be carefully monitored during the study period and the following tests and procedures will be performed: physical exams (weekly); blood collections (weekly); DC/Tumor Fusion study vaccine Journal (for the participant to record any side effects or other medications they may be taking); tumor cells skin test (before the first vaccine and one month following the last vaccine); skin biopsy at the site of the vaccination administration, accessible tumor site, or if there is a local reaction site.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 8 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dendritic Cell/Tumor Fusion Vaccine Only
Biological: Dendritic Cell/Tumor Fusion Vaccine
Dendritic Cell/tumor fusion vaccine and low dose IL-12
Biological: Dendritic Cell/Tumor Fusion Vaccine · Drug: Interleukin-12
Dendritic Cell/tumor fusion vaccine and higher dose IL-12
Biological: Dendritic Cell/Tumor Fusion Vaccine · Drug: Interleukin-12
Vaccine is derived from the participants dendritic cells and tumor cells
Also known as: DC/tumor cell fusion vaccine
Given subcutaneously at dose of 30ng/kg
Also known as: IL-12, rhIL-12
Given subcutaneously at dose of 100ng/kg
Also known as: IL-12, rhIL-12
Number of Participants With Adverse Events Associated With Vaccination of Breast Cancer Patients With Dendritic Cell (DC)/Tumor Fusion Vaccine
Using CTCAE version 3, adverse events associated with the intervention were captured throughout the treatment portion of the study. All adverse events were then compiled and the number of patients who experienced these adverse events was recorded.
Time frame: 3 years
To Determine if Cellular and Humoral Immunity is Induced by Serial Vaccination With DC/Tumor Fusion Cells and rhIL-12.
This outcome was not measured because no patients were treated with rhIL-12.
Time frame: 3 years
| Milestone | Group 1: Dendritic Cell/Tumor Fusion Vaccine Only | Group 2: Dendritic Cell/Tumor Fusion Vaccine and Low Dose IL-1 | Group 3: Dendritic Cell/Tumor Fusion Vaccine and Higher Dose I |
|---|---|---|---|
| Started | 6 | 2 | 0 |
| Completed | 3 | 0 | 0 |
| Not completed | 3 | 2 | 0 |
| Withdrew: Disease progression prior to treatment | 3 | 2 | 0 |
Using CTCAE version 3, adverse events associated with the intervention were captured throughout the treatment portion of the study. All adverse events were then compiled and the number of patients who experienced these adverse events was recorded.
| participants | Group 1 |
|---|---|
| Number of Participants With Adverse Events Associated With Vaccination of Breast Cancer Patients With Dendritic Cell (DC)/Tumor Fusion Vaccine | 3 |
This outcome was not measured because no patients were treated with rhIL-12.
No measurements were reported for this outcome.
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 | — | 0/3 (0%) | 3/3 (100%) |
| Event | Group 1 |
|---|---|
| Vaccine Site ReactionInvestigations | 2/3 |
| NauseaGastrointestinal disorders | 1/3 |
| MyalgiasGeneral disorders | 1/3 |
| RashGeneral disorders | 1/3 |
| PainNervous system disorders | 1/3 |
Females \>18yo with metastatic breast cancer
| Age, Categorical(Participants) | Group 1: Dendritic Cell/Tumor Fusion Vaccine Only | Group 2: Dendritic Cell/Tumor Fusion Vaccine and Low Dose IL-1 | Group 3: Dendritic Cell/Tumor Fusion Vaccine and Higher Dose I | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | — | 0 |
| Between 18 and 65 years | 4 | 2 | — | 6 |
| >=65 years | 2 | 0 | — | 2 |
| Sex: Female, Male(Participants) | Group 1: Dendritic Cell/Tumor Fusion Vaccine Only | Group 2: Dendritic Cell/Tumor Fusion Vaccine and Low Dose IL-1 | Group 3: Dendritic Cell/Tumor Fusion Vaccine and Higher Dose I | Total |
|---|---|---|---|---|
| Female | 6 | 2 | — | 8 |
| Male | 0 | 0 | — | 0 |
| Region of Enrollment(participants) | Group 1: Dendritic Cell/Tumor Fusion Vaccine Only | Group 2: Dendritic Cell/Tumor Fusion Vaccine and Low Dose IL-1 | Group 3: Dendritic Cell/Tumor Fusion Vaccine and Higher Dose I | Total |
|---|---|---|---|---|
| United States | 6 | 2 | — | 8 |
This study is terminated, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Beth Israel Deaconess Medical Center