Metastatic Breast CancerPhase 1AdHEReNCT00162929
Her-2/Neu in Patients With Metastatic Breast Cancer (AdHERe)
A Phase 1 study testing AdHer-2/neu transduced dendritic cells in people with Metastatic Breast Cancer, run by Ontario Clinical Oncology Group (OCOG).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- AdHer-2/neu transduced dendritic cells
- Type of treatment
- Injection or infusion
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to May 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- currently receiving hormonal therapy or are candidates for such, or
- being considered for trastuzumab, or
- cancer has progressed on trastuzumab.
Who cannot join
- Pregnant or lactating women.
- Prior or concurrent malignancies except for treated basal cell or squamous cell carcinoma of the skin or in situ cancer of the cervix or any other cancer treated and presumed cured for more than five years prior to study entry.
- Currently receiving chemotherapy, immunotherapy, adenoviral gene therapy or biological cancer therapy. [Note: concurrent hormonal therapy (tamoxifen, aromatase inhibitors, or megace) is permitted.]
- Treatment with trastuzumab within 4 weeks prior to first dose of vaccine therapy.
- Hemoglobin < 80 g/L or granulocytes < 1.5 × 10^9/L or lymphocytes < 1.0 × 10^9/L or platelets < 100 × 10^9/L.
- Baseline liver enzymes (AST or ALT) greater than 3 times the upper limit of normal or greater than 5 times the upper limit of normal if liver metastases are present and/or bilirubin is greater than 50 mmol.
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- CD4 cells < 0.5 ×10^9/L
- Patients with documented brain metastases.
- Patients with any acute illness that would interfere with the collection of CD34+ cells or administration of vaccination cellular therapy (i.e. unstable angina, renal or liver failure, or severe chronic obstructive airway disease).
- Any patients requiring concurrent immunosuppressive therapy (e.g. corticosteroids).
- Eastern Cooperative Oncology Group (ECOG) performance status of > 2.
- Patients with a life expectancy of less than 6 months.
- Geographic inaccessibility which would preclude follow-up. Patients registered on the trial must be treated and followed at the Juravinski Cancer Center and the Henderson site of the Hamilton Health Sciences.
- Failure to give written informed consent.
- Baseline left ventricular ejection fraction (LVEF) < 55% by echocardiography or multigated acquisition (MUGA) scan.
About this study
Official title: A Phase I Study Investigating Multiple Injections of Autologous CD34+ Derived Dendritic Cells Transduced With an Adenovirus Expressing Rat Her-2/Neu in Patients With Metastatic or Locally Recurrent Breast Cancer
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.
- Conditions
- Metastatic Breast Cancer
- Being tested
- AdHer-2/neu transduced dendritic cells
- Keywords
- metastatic breast cancer, locally recurrent breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdHer-2/neu transduced dendritic cellsBiological
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
toxicity
Measured: weeks 4, 6, 7, 10, 14, 18, 22, 26
Secondary outcomes (1)
tumour response
Measured: Weeks 6, 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionJul 2009
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Cancer Research Network, Canadian Breast Cancer Research Alliance
- Responsible party
- Sponsor
- Investigators
- Sukhbinder Dhesy-Thind, M.D., Study chair, Ontario Clinical Oncology Group; Juravinski Cancer Centre - Hamilton Health Sciences; McMaster UniversityRonan Foley, M.D., Principal investigator, McMaster UniversityRichard Tozer, M.D., Principal investigator, Juravinski Cancer Centre - Hamilton Health SciencesPeter Ellis, M.D., Principal investigator, Juravinski Cancer Centre - Hamilton Health SciencesJack Gauldie, M.D., Principal investigator, McMaster UniversityMark Levine, M.D., Principal investigator, Ontario Clinical Oncology Group (OCOG)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00162929
- Sponsor's protocol ID
- CTA-Control-092517
- Acronym
- AdHERe
- Status last verified
- May 2012
- First submitted
- 10 Sep 2005
- Last updated
- 4 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Investigating Multiple Injections of Autologous CD34+ Derived Dendritic Cells Transduced With an Adenovirus Expressing Rat Her-2/Neu in Patients With Metastatic or Locally Recurrent Breast Cancer
- ClinicalTrials.gov ID
- NCT00162929
- Acronym / sponsor ID
- AdHERe / CTA-Control-092517
- Conditions
- Metastatic Breast Cancer
- Keywords
- metastatic breast cancer, locally recurrent breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)University, hospital or other
- Collaborators
- Ontario Cancer Research Network, Canadian Breast Cancer Research Alliance
- Study start
- Jan 2005
- Primary completion
- Jul 2009 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 13 Sep 2005 (estimated)
- Results
- Not posted in the source record
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (15 listed)
- Pregnant or lactating women.
- Prior or concurrent malignancies except for treated basal cell or squamous cell carcinoma of the skin or in situ cancer of the cervix or any other cancer treated and presumed cured for more than five years prior to study entry.
- Currently receiving chemotherapy, immunotherapy, adenoviral gene therapy or biological cancer therapy. [Note: concurrent hormonal therapy (tamoxifen, aromatase inhibitors, or megace) is permitted.]
- Treatment with trastuzumab within 4 weeks prior to first dose of vaccine therapy.
- Hemoglobin < 80 g/L or granulocytes < 1.5 × 10^9/L or lymphocytes < 1.0 × 10^9/L or platelets < 100 × 10^9/L.
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 |
|---|---|---|
| AdHer-2/neu transduced dendritic cellsGroup 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) | Biological | – |
Primary outcome
toxicity
Time frame: weeks 4, 6, 7, 10, 14, 18, 22, 26
1 secondary outcome
tumour response
Time frame: Weeks 6, 18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2012.
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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.
Sukhbinder Dhesy-Thind, M.D. study chair
Ontario Clinical Oncology Group; Juravinski Cancer Centre - Hamilton Health Sciences; McMaster University
Ronan Foley, M.D. principal investigator
McMaster University
Richard Tozer, M.D. principal investigator
Juravinski Cancer Centre - Hamilton Health Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AdHer-2/neu transduced dendritic cells in people with Metastatic Breast Cancer, run by Ontario Clinical Oncology Group (OCOG).
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 7 inclusion and 15 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: finished, as of the sponsor's last update on 4 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
toxicity (time frame: weeks 4, 6, 7, 10, 14, 18, 22, 26). 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 4 Jun 2012.