Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Ontario Clinical Oncology Group (OCOG) Ontario Cancer Research Network Canadian Breast Cancer Research Alliance |
---|---|
Information provided by: | Ontario Clinical Oncology Group (OCOG) |
ClinicalTrials.gov Identifier: | NCT00162929 |
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.
Condition | Intervention | Phase |
---|---|---|
Metastatic Breast Cancer |
Biological: AdHer-2/neu transduced dendritic cells |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy 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 |
Estimated Enrollment: | 18 |
Study Start Date: | January 2005 |
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, Ontario | |
Juravinski Cancer Centre | Recruiting |
Hamilton, Ontario, Canada, L8V 5C2 | |
Contact: Sukhbinder Dhesy-Thind, M.D. 905-387-9711 ext 64602 Bindi.Dhesy@jcc.hhsc.ca | |
Principal Investigator: Sukhbinder Dhesy-Thind, M.D. |
Study Chair: | Sukhbinder Dhesy-Thind, M.D. | Ontario Clinical Oncology Group; Juravinski Cancer Centre - Hamilton Health Sciences; McMaster University |
Principal Investigator: | Ronan Foley, M.D. | McMaster University |
Principal Investigator: | Richard Tozer, M.D. | Juravinski Cancer Centre - Hamilton Health Sciences |
Principal Investigator: | Peter Ellis, M.D. | Juravinski Cancer Centre - Hamilton Health Sciences |
Principal Investigator: | Jack Gauldie, M.D. | McMaster University |
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-092517 |
Study First Received: | September 10, 2005 |
Last Updated: | November 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00162929 |
Health Authority: | Canada: Health Canada |
metastatic breast cancer locally recurrent breast cancer |
Skin Diseases Adenoviridae Infections Breast Neoplasms Breast Diseases Recurrence |
Neoplasms Neoplasms by Site |