Fusions of Breast Carcinoma and Dendritic Cells as a Vaccine for the Treatment of Metatastic Breast Cancer
Abstract
The main objective of the study is to determine the safety, immunologic response, and clinical effect of vaccination with dendritic cell (DC)/breast cancer fusions administered in conjunction with IL-12 to patients with metastatic breast cancer. DC/breast carcinoma fusion cells present a broad array of tumor-associated antigens in the context of DC-mediated costimulation. In clinical studies, vaccination with fusion cells was well tolerated, induced immunologic responses in a majority of patients, and resulted in disease regression in subset. We postulated that administration of the vaccine in conjunction with IL-12 would further enhance vaccine response by promoting T cell activation. In this study, we are conducting a phase I/II clinical trial in which patients with metastatic breast cancer undergo vaccination with DC/tumor fusions administered in conjunction with rhIL-12. An initial cohort of patients was treated with the DC/tumor fusions alone. In the subsequent cohort, fusion cells are being administered with rhIL-12 given subcutaneously at the time of vaccine administration and on days 3 and 5. Measures of tumor specific cellular and humoral immunity are being obtained at serial time points following vaccination. Time to disease progression and RECIST measurable disease response will be followed as a secondary endpoint.
Document Details
- Document Type
- Technical Report
- Publication Date
- Jul 01, 2012
- Accession Number
- ADA563220
Entities
People
- Baldev Vasir
- David Avigan
- Donald Kufe
Organizations
- Dana–Farber Cancer Institute