Breast CancerPhase 1/2NCT00622401
Vaccination of Patients With Breast Cancer With Dendritic Cell/Tumor Fusions and IL-12
A Phase 1/2 study testing Dendritic Cell/Tumor Fusion Vaccine and Interleukin-12 in people with Breast Cancer, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Dendritic Cell/Tumor Fusion Vaccine and Interleukin-12
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Oct 2014
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage IV breast cancer with measurable disease and accessible tumor
- ECOG Performance Status 0-2 with greater than six week life expectancy
- 18 years of age or older
- Laboratory values as outlined in the protocol
Who cannot join
- Patients must not have received other immunotherapy treatment in the three months prior to the initial vaccination
- Patients may not be on herceptin therapy during this protocol and may not have received it for four weeks prior to initial vaccination
- Patients must not have received weekly chemotherapy or hormonal treatment for two weeks prior to the initial vaccination and must not have received monthly chemotherapy for four weeks prior to the initial vaccination
- Clinical evidence of CNS disease
- Clinically significant autoimmune disease
- Patients who are HIV+
- Serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure
- Pregnant of lactating women will be excluded, all premenopausal women must undergo pregnancy testing
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
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.
Read the detailed description
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.
- Conditions
- Breast Cancer
- Being tested
- Dendritic Cell/Tumor Fusion Vaccine, Interleukin-12
- Keywords
- stage IV breast cancer, dendritic cell vaccine, tumor fusion vaccine, IL-12
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dendritic Cell/Tumor Fusion VaccineBiological
Also called DC/tumor cell fusion vaccine
Vaccine is derived from the participants dendritic cells and tumor cells
Interleukin-12Drug
Also called IL-12, rhIL-12
Given subcutaneously at dose of 30ng/kg
Interleukin-12Drug
Also called IL-12, rhIL-12
Given subcutaneously at dose of 100ng/kg
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Dendritic Cell/Tumor Fusion Vaccine Only Receives: Biological: Dendritic Cell/Tumor Fusion Vaccine |
| Group 2 | Experimental | Dendritic Cell/tumor fusion vaccine and low dose IL-12 Receives: Biological: Dendritic Cell/Tumor Fusion Vaccine; Drug: Interleukin-12 |
| Group 3 | Experimental | Dendritic Cell/tumor fusion vaccine and higher dose IL-12 Receives: Biological: Dendritic Cell/Tumor Fusion Vaccine; Drug: Interleukin-12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (1)
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
- Study startDec 2009
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Brigham and Women's Hospital, Harvard Medical School (HMS and HSDM), United States Department of Defense, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, David Avigan, MD, Dana-Farber Cancer Institute
- Investigators
- David Avigan, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622401
- Sponsor's protocol ID
- 03-221
- Other IDs
- NCI 6040, U01CA062490, P30CA006516
- Status last verified
- Oct 2017
- First submitted
- 14 Feb 2008
- Last updated
- 14 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccination of Patients With Breast Cancer With Dendritic Cell/Tumor Fusions and IL-12
- ClinicalTrials.gov ID
- NCT00622401
- Acronym / sponsor ID
- 03-221
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, dendritic cell vaccine, tumor fusion vaccine, IL-12
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Brigham and Women's Hospital, Harvard Medical School (HMS and HSDM), United States Department of Defense, National Cancer Institute (NCI)
- Study start
- Dec 2009
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 25 Feb 2008 (estimated)
- Results
- Posted 16 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: Dendritic Cell/Tumor Fusion VaccineDendritic Cell/Tumor Fusion Vaccine Only |
| Group 2 | Experimental | Biological: Dendritic Cell/Tumor Fusion Vaccine, Drug: Interleukin-12Dendritic Cell/tumor fusion vaccine and low dose IL-12 |
| Group 3 | Experimental | Biological: Dendritic Cell/Tumor Fusion Vaccine, Drug: Interleukin-12Dendritic Cell/tumor fusion vaccine and higher dose IL-12 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stage IV breast cancer with measurable disease and accessible tumor
- ECOG Performance Status 0-2 with greater than six week life expectancy
- 18 years of age or older
- Laboratory values as outlined in the protocol
Key exclusion criteria (8 listed)
- Patients must not have received other immunotherapy treatment in the three months prior to the initial vaccination
- Patients may not be on herceptin therapy during this protocol and may not have received it for four weeks prior to initial vaccination
- Patients must not have received weekly chemotherapy or hormonal treatment for two weeks prior to the initial vaccination and must not have received monthly chemotherapy for four weeks prior to the initial vaccination
- Clinical evidence of CNS disease
- Clinically significant autoimmune disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dendritic Cell/Tumor Fusion VaccineAlso: DC/tumor cell fusion vaccineVaccine is derived from the participants dendritic cells and tumor cells | Biological | Group 1, Group 2, Group 3 |
| Interleukin-12Also: IL-12, rhIL-12Given subcutaneously at dose of 30ng/kg | Drug | Group 2 |
| Interleukin-12Also: IL-12, rhIL-12Given subcutaneously at dose of 100ng/kg | Drug | Group 3 |
Primary outcome
Number of Participants With Adverse Events Associated With Vaccination of Breast Cancer Patients With Dendritic Cell (DC)/Tumor Fusion Vaccine
Time frame: 3 years
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.
1 secondary outcome
To Determine if Cellular and Humoral Immunity is Induced by Serial Vaccination With DC/Tumor Fusion Cells and rhIL-12.
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Avigan, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dendritic Cell/Tumor Fusion Vaccine and Interleukin-12 in people with Breast Cancer, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events Associated With Vaccination of Breast Cancer Patients With Dendritic Cell (DC)/Tumor Fusion Vaccine (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.