Status:
COMPLETED
Administration of Autologous Dendritic Cells (DCs) Infected With an Adenovirus Expressing Her-2
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
Ontario Cancer Research Network
Canadian Breast Cancer Research Alliance
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
16-80 years
Phase:
PHASE1
Brief Summary
We, the researchers at Hamilton Health Sciences, have developed a novel approach to cancer therapy using transfected dendritic cells (DCs) to generate enhanced immunity to defined tumor antigens. Dend...
Detailed Description
Following written, informed consent, consecutive cohorts of 3-6 patients, up to a maximum of 18 patients, will be treated at increasing dose levels based on a modified Fibonacci scheme. Peripheral blo...
Eligibility Criteria
Inclusion
- Patients with metastatic breast cancer who are HER2/neu positive (3+ by immunohistochemistry or FISH positive) and either
- currently receiving hormonal therapy or are candidates for such or
- being considered for trastuzumab or
- their cancer has progressed on trastuzumab
Exclusion
- Patients are excluded from the study if they meet any one of the following criteria:
- Age less than 16 years.
- Pregnant or lactating female.
- Previous malignancy other than non-melanoma skin cancer.
- More than three prior courses of cytotoxic chemotherapy for metastatic disease.
- Concurrent use of chemotherapy, immunotherapy, or gene therapy. Concurrent hormonal therapy (tamoxifen, aromatase inhibitors or exemestane) is permitted.
- Treatment with trastuzumab within 16 weeks prior to first dose of vaccine therapy.
- Documented central nervous system metastases.
- Patients with any an acute illness that would interfere with the mobilization of stem cells or the administration of vaccination cellular therapy (ie. unstable angina, renal or liver failure, or severe chronic obstructive airways disease) are ineligible.
- Any patients requiring concurrent immunosuppressive therapy (eg. corticosteroids)
- Patients with a life expectancy of less than six months.
- ECOG performance status of \>2.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00197522
Start Date
October 1 2004
End Date
May 1 2012
Last Update
November 1 2012
Active Locations (1)
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1
Hamilton Health Sciences
Hamilton, Ontario, Canada, M8V 1C3