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Multipeptide Vaccine for Advanced Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00573495
First Posted: December 14, 2007
Last Update Posted: September 29, 2016
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.
Information provided by (Responsible Party):
University of Pennsylvania
  Purpose

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:

  1. to test the safety of the combination of agents
  2. to find out what effects the treatment has on advanced breast cancer

Condition Intervention Phase
Breast Neoplasm Breast Cancer Cancer of the Breast Carcinoma, Ductal Biological: hTERT/Survivin Multi-Peptide Vaccine Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of hTERT/Survivin Multi-peptide Vaccine With Daclizumab and Prevnar for Patients With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Safety [ Time Frame: Up to 30 days after the last vaccination ]

Secondary Outcome Measures:
  • Immunologic response [ Time Frame: After 4th vaccination, then after every 3-4 vaccinations, and then every 6 months ]

Enrollment: 11
Study Start Date: November 2007
Study Completion Date: February 2013
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Names:
  • hTERT
  • Telomerase

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stage IV breast cancer that has failed at least one conventional therapy for metastatic disease
  • HLA-A2 positive
  • Measurable or evaluable disease
  • ECOG performance status 0-1
  • Negative contrast CT or MRI scan of the brain within 30 days of treatment
  • Negative pregnancy test within 14 days of treatment for women of childbearing potential

Exclusion Criteria:

  • History of brain metastases within the last 4 years
  • The use of chemotherapy, radiation therapy, immunosuppressive drugs, systemic glucocorticoids, growth factors, or experimental therapy, and anti-coagulants within 14 days prior to treatment
  • Initiation of hormonal agent in the 30 days before treatment
  • Initiation of Herceptin in the 30 days prior to treatment.
  • History of bone marrow or stem cell transplantation
  • Pregnant or lactating
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Pennsylvania
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19341
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Kevin Fox, MD University of Pennsylvania
  More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00573495     History of Changes
Other Study ID Numbers: UPCC 08107
First Submitted: December 12, 2007
First Posted: December 14, 2007
Last Update Posted: September 29, 2016
Last Verified: September 2016

Keywords provided by University of Pennsylvania:
Advanced breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma, Ductal
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary
Vaccines
Immunologic Factors
Physiological Effects of Drugs