NCT02479230

Type I-Polarized Autologous Dendritic Cell Vaccine With Tumor Blood Vessel Antigen-Derived Peptides in Metastatic Breast Cancer Patients

Pilot Trial of Type I-Polarized Autologous Dendritic Cell Vaccine Incorporating Tumor Blood Vessel Antigen-Derived Peptides in Patients With Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Joseph Baar, MD, PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies the safety of a dendritic cell vaccine when given with gemcitabine hydrochloride in treating patients with breast cancer that has spread beyond the breast and local lymph nodes to other organs in the body. The vaccine is made up of natural cells found in the blood, called dendritic cells, and peptides, or small fragments of protein which are loaded onto the dendritic cells. This combination may help activate the immune system against stromal cells, which are cells that help cancer cells survive in the body. Gemcitabine hydrochloride is a chemotherapy drug that is given before the vaccine to help shrink the tumor and control cells that may interfere with the activity of the vaccine. Interfering with the stromal cells that help support the growth of cancer cells may lead to the death of the cancer cells.

Detailed description

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.

Conditions

• Breast Cancer
• Metastatic Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	tumor blood vessel antigen peptide-pulsed alpha-type-1 polarized dendritic cell vaccine	Given ID
DRUG	gemcitabine hydrochloride	Given IV

Timeline

• Start date: 2015-07-17
• Primary completion: 2019-10-30
• Completion: 2022-07-01
• First posted: 2015-06-24
• Last updated: 2022-11-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study