Multipeptide Vaccine for Advanced Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00573495|
Recruitment Status : Completed
First Posted : December 14, 2007
Last Update Posted : September 29, 2016
This is a study on how to activate the immune system with a vaccine. The vaccine is made up of two proteins found in breast cancer: telomerase and survivin. The vaccine is given in combination with other drugs that may also have an effect on the immune system and attack the cancer.
The goals of the study are:
- to test the safety of the combination of agents
- to find out what effects the treatment has on advanced breast cancer
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasm Breast Cancer Cancer of the Breast Carcinoma, Ductal||Biological: hTERT/Survivin Multi-Peptide Vaccine||Phase 1|
Patients with advanced breast cancer may often fail standard of care treatments for metastatic disease. This research is studying a combinations of agents that impact the immune system.
About >85% of all human cancers, including breast cancer, express telomerase (hTERT) activity. Targeting hTERT immunologically may also minimize immune escape due to antigen loss because mutation or deletion of hTERT may be incompatible with sustained tumor growth. hTERT Multi-Peptide Vaccine is made up of 1540 hTERT peptide and cryptic peptides selected for "low-affinity" binding to HLA-A2 in order to increase the likelihood that the host immune system would ignore them, and then they have been modified by changing the first amino acid of the peptides to tyrosine in order to increase HLA - A2 affinity. The two "heteroclitic" peptides are R572Y (YLFFYRKSV) and D988Y (YLQVNSLQTV), which bind HLA-A2 with high avidity and elicit specific CTL (cytotoxic T lymphocyte) responses using healthy donor mononuclear cells in vitro. In addition, in mouse models, these peptide vaccines elicit lytic CTL responses which are protective against tumor challenges using a TERT-expressing murine tumor.
Subjects will also be immunized with a peptide vaccine derived from survivin, an important anti-apoptotic protein which is overexpressed in a broad range of malignancies including breast cancer. Survivin may be an ideal and "universal" tumor antigen since it is overexpressed in a wide variety of cancers yet terminally differentiated adult cells do not express the protein.
CMV derived CTL epitopes will be used as positive control peptides.
Daclizumab is a humanized anti-human CD25 monoclonal antibody that binds specifically to CD25 expressing cells, including Treg cells, and inhibits its proliferation.
Prevnar is designed to augment T-helper cell immunity.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of hTERT/Survivin Multi-peptide Vaccine With Daclizumab and Prevnar for Patients With Metastatic Breast Cancer|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||February 2013|
|Experimental: hTERT/Survivin Multi-Peptide Vaccine||
Biological: hTERT/Survivin Multi-Peptide Vaccine
100 mcg subcutaneous every 2 weeks four times, then monthly up to 28 vaccinations
- Safety [ Time Frame: Up to 30 days after the last vaccination ]
- Immunologic response [ Time Frame: After 4th vaccination, then after every 3-4 vaccinations, and then every 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00573495
|United States, Pennsylvania|
|University of Pennsylvania Medical Center|
|Philadelphia, Pennsylvania, United States, 19341|
|Principal Investigator:||Kevin Fox, MD||University of Pennsylvania|