Trials / Completed
CompletedNCT00162929
Her-2/Neu in Patients With Metastatic Breast Cancer (AdHERe)
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Ontario Clinical Oncology Group (OCOG) · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AdHer-2/neu transduced dendritic cells | Group 1 1 ×10'7 expanded cells (2.5 ×106 DCs per injection site) Group 2 5 ×10'7 expanded cells (1.25 ×107 DCs per injection site) Group 3 1 ×10'8 expanded cells (2.5 ×107 DCs per injection site) |
Timeline
- Start date
- 2005-01-01
- Primary completion
- 2009-07-01
- Completion
- 2012-05-01
- First posted
- 2005-09-13
- Last updated
- 2012-06-04
Source: ClinicalTrials.gov record NCT00162929. Inclusion in this directory is not an endorsement.