Novel Vaccine Study Opens at UCSF

A clinical trial will open exclusively at the UCSF Cancer Center in March, 2001. It involves a new dendritic cell vaccine for HER2/neu-positive patients with metastatic breast cancer. This novel study will be exclusive to UCSF. It is entitled " An Open-label Dose Escalation Study of Autologous Dendritic Cells Loaded with HER500ïGM-CSF (APC8024) in Patients with Metastatic Breast Cancer Over-expressing Her-2/neu". Drs. John W. Park and Laura J. Esserman will be leading the study.

This is a Phase I/II clinical trial of an autologous dendritic cell-based vaccine directed against HER2/neu. Dendritic cells, which are the most potent antigen presenting cells, are now appreciated to be critical to successful initiation of the immune response to cancer. Each patient will have her dendritic cells harvested and enriched, exposed to a recombinant antigen (HER500-GM-CSF) that combines HER2 sequences and GM-CSF sequences, and reinfused as a vaccine, designated APC8024.

For this study, patients will receive three doses of APC8024 on weeks 0, 2, and 4. This is a dose-escalation study, in which cohorts of patients will receive increasing numbers of cells in the infusion. The primary study endpoints are: the safety of this treatment; immunologic effects as indicated by antibody and T-cell responses against Her2/neu; and antitumor effects as indicated by response rate and time to disease progression.

Patients must be "HER2-positive," meaning overexpression as determined by immunohistochemistry (e.g., HerceptestÒ ) or gene amplification as determined by fluorescence in situ hybridization (FISH). Eligible patients may or may not have received prior anti-HER2 antibody (trastuzumab/HerceptinÒ ). Previous chemotherapy is allowed if not more than two regimens for metastatic cancer.

We are very excited about this study, and believe that it offers a promising new therapeutic option for patients with metastatic breast cancer. We welcome any questions and inquiries regarding this study, and we will make every effort to assist interested referring physicians and patients in setting up an initial evaluation. Questions regarding eligibility can also be directed to Clinical Research Study Coordinators Alison Lozner at (415) 885-7638 or Marina Kenzer at (415) 885-7328.