Status:
TERMINATED
Vaccination of Patients With Breast Cancer With Dendritic Cell/Tumor Fusions and IL-12
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to test the safety of an investigational Dendritic Cell/Tumor Fusion vaccine given with IL-12 for patients with breast cancer. RATIONALE: Vaccines made from a person's tu...
Detailed Description
TUMOR COLLECTION: Tumor cells will be collected from the participant to make the study vaccine. Based on the location of the tumor, a decision will be made as to the best approach to obtain these cell...
Eligibility Criteria
Inclusion
- Stage IV breast cancer with measurable disease and accessible tumor
- ECOG Performance Status 0-2 with greater than six week life expectancy
- 18 years of age or older
- Laboratory values as outlined in the protocol
Exclusion
- Patients must not have received other immunotherapy treatment in the three months prior to the initial vaccination
- Patients may not be on herceptin therapy during this protocol and may not have received it for four weeks prior to initial vaccination
- Patients must not have received weekly chemotherapy or hormonal treatment for two weeks prior to the initial vaccination and must not have received monthly chemotherapy for four weeks prior to the initial vaccination
- Clinical evidence of CNS disease
- Clinically significant autoimmune disease
- Patients who are HIV+
- Serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure
- Pregnant of lactating women will be excluded, all premenopausal women must undergo pregnancy testing
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00622401
Start Date
December 1 2009
End Date
October 1 2014
Last Update
November 14 2017
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215