Status:
COMPLETED
Adenovirus Encoding Rat HER-2 in Patients With Metastatic Breast Cancer (AdHER2.1)
Lead Sponsor:
Ontario Clinical Oncology Group (OCOG)
Collaborating Sponsors:
Ontario Cancer Research Network
Canadian Breast Cancer Research Alliance
Conditions:
Metastatic Breast Cancer
Recurrent Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00307229
Start Date
March 1 2006
End Date
May 1 2012
Last Update
June 4 2012
Active Locations (1)
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1
Sir Mortimer B. Davis - Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2