Vaccination of Patients With Breast Cancer With Dendritic Cell/Tumor Fusions and IL-12
NCT00622401 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2017-11-14
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 tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells. Interleukin-12 may stimulate the white blood cells to kill tumor cells. Giving vaccine therapy together with interleukin-12 may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of interleukin-12 when given together with vaccine therapy and to see how well they work in treating women with stage IV breast cancer.
Conditions
Interventions
- BIOLOGICAL
-
Dendritic Cell/Tumor Fusion Vaccine
Vaccine is derived from the participants dendritic cells and tumor cells
- DRUG
-
Interleukin-12
Given subcutaneously at dose of 30ng/kg
- DRUG
-
Interleukin-12
Given subcutaneously at dose of 100ng/kg
Sponsors & Collaborators
- collaborator OTHER
-
Brigham and Women's Hospital
collaborator OTHER -
Harvard Medical School (HMS and HSDM)
collaborator OTHER -
United States Department of Defense
collaborator FED -
National Cancer Institute (NCI)
collaborator NIH -
Beth Israel Deaconess Medical Center
lead OTHER
Principal Investigators
-
David Avigan, MD · Beth Israel Deaconess Medical Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-12-31
- Primary Completion
- 2014-10-31
- Completion
- 2014-10-31
Countries
- United States
Study Locations
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