- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00307229
Adenovirus Encoding Rat HER-2 in Patients With Metastatic Breast Cancer (AdHER2.1)
May 31, 2012 updated by: Ontario Clinical Oncology Group (OCOG)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3T 1E2
- Sir Mortimer B. Davis - Jewish General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
toxicity
Time Frame: Weeks 4, 6, 7, 10, 14, 18, 22, 26
|
Weeks 4, 6, 7, 10, 14, 18, 22, 26
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
tumour response
Time Frame: Weeks 6, 18
|
Weeks 6, 18
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mark Levine, M.D., Ontario Clinical Oncology Group (OCOG)
- Study Chair: Gerry Batist, M.D., Lady Davis Institute for Medical Research Jewish General Hospital
- Principal Investigator: Ronan Foley, M.D., Hamilton Health Sciences Corporation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
March 24, 2006
First Submitted That Met QC Criteria
March 24, 2006
First Posted (Estimate)
March 27, 2006
Study Record Updates
Last Update Posted (Estimate)
June 4, 2012
Last Update Submitted That Met QC Criteria
May 31, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTA-Control-100643
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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