Metastatic Breast CancerPhase 1NCT00307229
Adenovirus Encoding Rat HER-2 in Patients With Metastatic Breast Cancer (AdHER2.1)
A Phase 1 study testing adenoviral vector encoding rat Her-2/neu in people with Metastatic Breast Cancer and Recurrent Breast Cancer, run by Ontario Clinical Oncology Group (OCOG) at 1 site in Canada.
Trial summary
To determine the maximum tolerated dose and/or maximum attainable dose of a vaccine consisting of adenovector expressing rat Her-2/neu in patients with metastatic or locally recurrent breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, Recurrent Breast Cancer
- What is being tested?
- adenoviral vector encoding rat Her-2/neu
- Type of treatment
- Injection or infusion
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2006to 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 FISH +),
- One of the following
- currently receiving hormonal therapy or are candidates for such or,
- being considered for trastuzumab or,
- their cancer has progressed on trastuzumab
Who cannot join
- Pregnant or lactating women.
- Prior or concurrent malignancies except treated basal cell or squamous carcinoma of the skin or in situ cancer of the cervix or any other cancer treated and presumed cured 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 x 109 /L or lymphocytes < 1.0 x 109 /L or platelets < 100 x 109 /L.
- Baseline liver enzymes (AST or ALT) greater than 3 times upper limit of normal or greater than 5 times upper limit of normal if liver metastases present and/or bilirubin greater than 50 mmol.
Show all 15Show fewer
- CD4 cells < 0.5 x 109 /L
- Patients with documented brain metastases.
- Patients with any acute illness that would interfere with vaccination
- 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 Jewish General Hospital.
- Failure to give written informed consent.
- Baseline left ventricular ejection fraction (LVEF) < 55% by echocardiography or MUGA scan.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Sir Mortimer B. Davis - Jewish General Hospital
Montreal, Quebec, H3T 1E2
About this study
Official title: A Phase I Trial Investigating the Safety and Immunogenicity of an Adenovirus Encoding Rat HER-2 Administered Intradermally to Patients With Metastatic or Locally Recurrent Breast Cancer
To determine the maximum tolerated dose and/or maximum attainable dose of a vaccine consisting of adenovector expressing rat Her-2/neu in patients with metastatic or locally recurrent breast cancer.
- Conditions
- Metastatic Breast Cancer, Recurrent Breast Cancer
- Being tested
- adenoviral vector encoding rat Her-2/neu
- Keywords
- metastatic breast cancer, 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.
adenoviral vector encoding rat Her-2/neuBiological
Group 1 1 x 10'7 pfu (2.5 X 10'6 pfu per injection site)(1.6 x 10'9 particles) Group 2 5 x 10'7 pfu (1.25 X 10'7 pfu per injection site)(8.0 x10'9 particles) Group 3 1 x 10'8 pfu (5 x 10'7 pfu per injection site)(1.6 x10'10 particles)
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 posted27 Mar 2006 (estimated)
- Study startMar 2006
- 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
- 8 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
- Gerry Batist, M.D., Study chair, Lady Davis Institute for Medical Research Jewish General HospitalRonan Foley, M.D., Principal investigator, Hamilton Health Sciences CorporationMark Levine, M.D., Principal investigator, Ontario Clinical Oncology Group (OCOG)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00307229
- Sponsor's protocol ID
- CTA-Control-100643
- Status last verified
- May 2012
- First submitted
- 24 Mar 2006
- Last updated
- 4 Jun 2012
- Results posted
- No
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 Trial Investigating the Safety and Immunogenicity of an Adenovirus Encoding Rat HER-2 Administered Intradermally to Patients With Metastatic or Locally Recurrent Breast Cancer
- ClinicalTrials.gov ID
- NCT00307229
- Acronym / sponsor ID
- CTA-Control-100643
- Conditions
- Metastatic Breast Cancer, Recurrent Breast Cancer
- Keywords
- metastatic breast cancer, recurrent breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 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
- Mar 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 27 Mar 2006 (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.
To determine the maximum tolerated dose and/or maximum attainable dose of a vaccine consisting of adenovector expressing rat Her-2/neu in patients with metastatic or locally recurrent 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 FISH +),
- One of the following
Key exclusion criteria (15 listed)
- Pregnant or lactating women.
- Prior or concurrent malignancies except treated basal cell or squamous carcinoma of the skin or in situ cancer of the cervix or any other cancer treated and presumed cured 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 x 109 /L or lymphocytes < 1.0 x 109 /L or platelets < 100 x 109 /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 |
|---|---|---|
| adenoviral vector encoding rat Her-2/neuGroup 1 1 x 10'7 pfu (2.5 X 10'6 pfu per injection site)(1.6 x 10'9 particles) Group 2 5 x 10'7 pfu (1.25 X 10'7 pfu per injection site)(8.0 x10'9 particles) Group 3 1 x 10'8 pfu (5 x 10'7 pfu per injection site)(1.6 x10'10 particles) | 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.
Related trials for Metastatic Breast Cancer
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
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.
Gerry Batist, M.D. study chair
Lady Davis Institute for Medical Research Jewish General Hospital
Ronan Foley, M.D. principal investigator
Hamilton Health Sciences Corporation
Mark Levine, M.D. principal investigator
Ontario Clinical Oncology Group (OCOG)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing adenoviral vector encoding rat Her-2/neu in people with Metastatic Breast Cancer and Recurrent Breast Cancer, run by Ontario Clinical Oncology Group (OCOG) at 1 site in Canada.
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.
Where is the study taking place?
The record lists 1 site in Canada. 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 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.