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Sponsors and Collaborators: |
Ontario Clinical Oncology Group (OCOG) Ontario Cancer Research Network Canadian Breast Cancer Research Alliance |
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Information provided by: | Ontario Clinical Oncology Group (OCOG) |
ClinicalTrials.gov Identifier: | NCT00307229 |
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.
Condition | Intervention | Phase |
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Metastatic Breast Cancer Recurrent Breast Cancer |
Biological: adenoviral vector encoding rat Her-2/neu |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy 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 |
Estimated Enrollment: | 18 |
Study Start Date: | March 2006 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
One of the following
Exclusion Criteria:
Contact: Lorraine Weise-Kelly, Ph.D. | 905-527-2299 ext 43772 | kellyla@mcmaster.ca |
Contact: Anita Polgar | 905-527-2299 ext 42648 | polgara@mcmaster.ca |
Canada, Quebec | |
Sir Mortimer B. Davis - Jewish General Hospital | Recruiting |
Montreal, Quebec, Canada, H3T 1E2 | |
Sub-Investigator: Michael Pollak, M.D. | |
Sub-Investigator: Francois Patenaude, M.D. | |
Sub-Investigator: Lawrence C Panasci, M.D. | |
Sub-Investigator: Wilson H Miller, M.D. | |
Sub-Investigator: David Malnychuk, M.D. | |
Sub-Investigator: Adrian Langleben, M.D. | |
Sub-Investigator: Victor Cohen, M.D. | |
Principal Investigator: Gerald Batist, M.D. |
Study Chair: | Gerry Batist, M.D. | Lady Davis Institute for Medical Research Jewish General Hospital |
Principal Investigator: | Ronan Foley, M.D. | Hamilton Health Sciences |
Principal Investigator: | Mark Levine, M.D. | Ontario Clinical Oncology Group |
Responsible Party: | Ontario Clinical Oncology Group ( Dr. Mark Levine/Director OCOG ) |
Study ID Numbers: | CTA-Control-100643 |
Study First Received: | March 24, 2006 |
Last Updated: | June 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00307229 |
Health Authority: | Canada: Health Canada |
metastatic breast cancer recurrent breast cancer |
Skin Diseases Adenoviridae Infections Breast Neoplasms Breast Diseases Recurrence |
Disease Attributes Neoplasms Pathologic Processes Neoplasms by Site |