Finding studies
Finding studies
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Lead
Joseph Baar, MD, PhD
PRIMARY OBJECTIVES: I. Assess the safety of gemcitabine hydrochloride (GEM) + alpha-type-1 dendritic cell (αDC1)-tumor blood vessel antigen (TBVA) vaccination (tumor blood vessel antigen peptide-pulsed alpha-type-1 polarized dendritic cell vaccine). II. Assess the clinical response of metastatic breast cancer (MBC) to GEM + αDC1-TBVA vaccination. III. Determine the clinical efficacy of GEM + αDC1-TBVA vaccination in generating T-helper 1 cell (Tc1) immunity. IV. Correlate changes in myeloid-derived suppressor cells (MDSC) and regulatory T cells (Tregs) with the generation of anti-TBVA T-cell immunity. OUTLINE: Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 3 courses. Beginning 3, 7, or 10 days later, patients receive tumor blood vessel antigen peptide-pulsed alpha-type-1 polarized dendritic cell vaccine intradermally (ID) followed by a second vaccination 7 days later. Courses may repeat after at least 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
