A Study of hTERT/Survivin Multi-Peptide Vaccination With Basiliximab And Prevnar For Patients With Metastatic Breast Cancer
hTERT is widely found in breast cancer cells and has a role in tumor growth and development,
making it attractive for immunotherapy. Also, recent data suggest that breast cancer is
potentially responsive to immunological therapies. In one trial, patients with advanced
cancer received a series of hTERT vaccinations and 4 of 7 patients with advanced breast or
prostate carcinoma developed hTERT-specific T lymphocytes. Partial tumor regression was
observed in 1 patient. In a second trial, 19 HLA A2+ patients with metastatic breast cancer
were vaccinated with hTERT 1540 peptide in adjuvant with GM-CSF. 68% of patients exhibited
immunological responses with development of CD8+ hTERT-specific T-cells. Overall survival
of vaccine responders was signifiantly better than the overall survival on non-responders.
In order to expand the number of possible immune responses and to potentially bypass immune
tolerance, multiple peptides have been added to the vaccine. In addition, the monoclonal
antibody basiliximab is included to decrease the regulatory T cells which prevent the immune
system to work against the tumor, and GM-CSF and Prevnar are used to boost the immune
system. Subjects will receive a maximum of 28 vaccinations over a 24 months period.
Interventional
Primary Purpose: Treatment
Number of Adverse Events
Yes
Kevin Fox, MD
Principal Investigator
Abramson Cancer Center of the University of Pennsylvania
United States: Food and Drug Administration
UPCC 03111
NCT01660529
June 2012
June 2018
Name | Location |
---|---|
Abramson Cancer Center, University of Pennsylvania | Philadelphia, Pennsylvania 19104 |