Breast NeoplasmPhase 1NCT00573495
Multipeptide Vaccine for Advanced Breast Cancer
A Phase 1 study testing hTERT/Survivin Multi-Peptide Vaccine in people with Breast Neoplasm and Breast Cancer, run by University of Pennsylvania at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasm, Breast Cancer, Cancer of the Breast
- What is being tested?
- hTERT/Survivin Multi-Peptide Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Feb 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19341
About this study
Official title: A Study of hTERT/Survivin Multi-peptide Vaccine With Daclizumab and Prevnar for Patients With Metastatic Breast Cancer
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
Read the 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.
- Being tested
- hTERT/Survivin Multi-Peptide Vaccine
- Keywords
- Advanced breast cancer
- Medical subject headings
- Breast Neoplasms, Carcinoma, Ductal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hTERT/Survivin Multi-Peptide VaccineBiological
Also called hTERT, Telomerase
100 mcg subcutaneous every 2 weeks four times, then monthly up to 28 vaccinations
| Study group | Role | What they receive |
|---|---|---|
| hTERT/Survivin Multi-Peptide Vaccine | Experimental | Not described Receives: Biological: hTERT/Survivin Multi-Peptide Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Measured: Up to 30 days after the last vaccination
Secondary outcomes (1)
Immunologic response
Measured: After 4th vaccination, then after every 3-4 vaccinations, and then every 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2007 (estimated)
- Study startNov 2007
- Primary completionJul 2011
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Fox, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00573495
- Sponsor's protocol ID
- UPCC 08107
- Status last verified
- Sep 2016
- First submitted
- 12 Dec 2007
- Last updated
- 29 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of hTERT/Survivin Multi-peptide Vaccine With Daclizumab and Prevnar for Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00573495
- Acronym / sponsor ID
- UPCC 08107
- Keywords
- Advanced breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Jul 2011 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 14 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hTERT/Survivin Multi-Peptide Vaccine | Experimental | Biological: hTERT/Survivin Multi-Peptide Vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hTERT/Survivin Multi-Peptide VaccineAlso: hTERT, Telomerase100 mcg subcutaneous every 2 weeks four times, then monthly up to 28 vaccinations | Biological | hTERT/Survivin Multi-Peptide Vaccine |
Primary outcome
Safety
Time frame: Up to 30 days after the last vaccination
1 secondary outcome
Immunologic response
Time frame: After 4th vaccination, then after every 3-4 vaccinations, and then every 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Fox, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing hTERT/Survivin Multi-Peptide Vaccine in people with Breast Neoplasm and Breast Cancer, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: Up to 30 days after the last vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2016.