Metastatic Breast CancerEarly Phase 1NCT01660529
Multi-peptide Vaccine With Basilixumab for Breast Cancer
A Early Phase 1 study testing hTERT in people with Metastatic Breast Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
Eligible patients will receive subcutaneous vaccinations of the hTERT/survivin/CMV multipeptide vaccine and GM-CSF over a 24 month period. All patients will receive basiliximab 20 mg 1 day prior to the start of vaccinations. Prevnar vaccine will be administered at the time of Vaccines 1,3, and 5. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- hTERT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to 20 Nov 2015
- Phase
- Early 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 (AJCC) breast cancer patients who have failed at least one conventional therapy for metastatic disease.
- HLA-A2 blood positive
- Evidence of measurable or evaluable disease by clinical, radiographic, or laboratory assessment.
- Age greater than 18 years old
- Baseline Eastern Cooperative Oncology Group (ECOG) Clinical Performance Status 0 or 1
- Life expectancy greater than 6 months
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- Adequate hematologic function established within 14 days before treatment: WBC equal to or greater than 3.0, Plt equal to or greater than 75,000, Hgb equal to or greater than 10 g/dl
- Adequate renal function established within 14 days before treatment defined as serum creatinine less than 1.5 times upper limit of normal
- Adequate hepatic function established within 14 days before treatment defined as: Total bilirubin, less than 1.5 times upper limit of normal, and ALT and AST less than 2.5 times upper limit of normal
- Contrast CT and/or MRI of the brain negative for central nervous system metastases within 30 days of treatment
- Women of child bearing potential must have a negative pregnancy test (blood or urine) within 14 days before treatment and agree to use appropriate contraception from study screen through the duration of the trial. Men must agree to use appropriate contraception from study screen through the duration of the trial.
- Signed and dated written informed consent
Who cannot join
- History of brain metastases within the last four years
- Positivity for HIV-1/HIV-2, Hepatitis B virus, and Hepatitis C virus active infection
- The use of the following within 14 days before treatment: Chemotherapy, Radiation therapy, Immunosuppressive drugs, Systemic glucocorticoids, Hematopoietic growth factors, Experimental therapy
- Use of anti-coagulants such as coumadin, heparin, or Lovenox within 14 days before treatment, with the exception of low dose anti-coagulants to maintain intravenous catheter patency.
- Initiation of hormonal agent (such as tamoxifen, anastrazole, or letrozole) in the 30 days before treatment. 6. Patients who have been on a hormonal agent for at least 30 days prior to treatment with progressive or stable disease are permitted to enroll, but required to stay on this hormonal agent for the duration of the study.
- Initiation of immunotherapy (such as trastuzumab-Herceptin) in the 30 days before treatment. Patients who have been on trastuzumab for at least 30 days prior to treatment with progressive or stable disease are permitted to enroll, but required to stay on trastuzumab for the duration of the study.
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- History of bone marrow or stem cell transplantation (allogeneic or autologous)
- Pregnant women or nursing mothers
- History of alcohol abuse or illicit drug use within 12 months of study initiation
- Clinically significant comorbid disease or other underlying condition, including major autoimmune disorders that would contraindicate study therapy or confuse interpretation of study results
- Significant psychiatric disorder and any other reason in the Investigators opinion that would jeopardize protocol compliance or compromise the patients ability to give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Study of hTERT/Survivin Multi-Peptide Vaccination With Basiliximab And Prevnar For Patients With Metastatic Breast Cancer
Eligible patients will receive subcutaneous vaccinations of the hTERT/survivin/CMV multipeptide vaccine and GM-CSF over a 24 month period. All patients will receive basiliximab 20 mg 1 day prior to the start of vaccinations. Prevnar vaccine will be administered at the time of Vaccines 1,3, and 5. Patients who remain clinically stable after the fourth vaccine, may continue to receive vaccinations every 4 weeks for up to 2 years.
Read the detailed description
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.
- Conditions
- Metastatic Breast Cancer
- Being tested
- hTERT
- Keywords
- Subjects with metastatic breast cancer who have failed at least one standard, of care regimen
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hTERTBiological
| Study group | Role | What they receive |
|---|---|---|
| hTERT/Survivin Multi-Peptide Vaccination | Experimental | single-arm Phase I study for patients with metastatic breast cancer who have failed at least one regimen for metastatic disease Receives: Biological: hTERT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Measured: 1st dose of basiliximab to 30 days after the last vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2012 (estimated)
- Study startJun 2012
- Primary completion20 Nov 2015
- Study completion20 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Fox, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01660529
- Sponsor's protocol ID
- UPCC 03111
- Status last verified
- Jun 2019
- First submitted
- 6 Aug 2012
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of hTERT/Survivin Multi-Peptide Vaccination With Basiliximab And Prevnar For Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01660529
- Acronym / sponsor ID
- UPCC 03111
- Conditions
- Metastatic Breast Cancer
- Keywords
- Subjects with metastatic breast cancer who have failed at least one standard, of care regimen
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- 20 Nov 2015 (actual)
- Study completion
- 20 Nov 2015 (actual)
- First posted
- 8 Aug 2012 (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.
Eligible patients will receive subcutaneous vaccinations of the hTERT/survivin/CMV multipeptide vaccine and GM-CSF over a 24 month period. All patients will receive basiliximab 20 mg 1 day prior to the start of vaccinations. Prevnar vaccine will be administered at the time of Vaccines 1,3, and 5. Patients who remain clinically stable after the fourth vaccine, may continue to receive vaccinations every 4 weeks for up to 2 years.
Detailed description
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.
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 Vaccination | Experimental | Biological: hTERTsingle-arm Phase I study for patients with metastatic breast cancer who have failed at least one regimen for metastatic disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Stage IV (AJCC) breast cancer patients who have failed at least one conventional therapy for metastatic disease.
- HLA-A2 blood positive
- Evidence of measurable or evaluable disease by clinical, radiographic, or laboratory assessment.
- Age greater than 18 years old
- Baseline Eastern Cooperative Oncology Group (ECOG) Clinical Performance Status 0 or 1
Key exclusion criteria (11 listed)
- History of brain metastases within the last four years
- Positivity for HIV-1/HIV-2, Hepatitis B virus, and Hepatitis C virus active infection
- The use of the following within 14 days before treatment: Chemotherapy, Radiation therapy, Immunosuppressive drugs, Systemic glucocorticoids, Hematopoietic growth factors, Experimental therapy
- Use of anti-coagulants such as coumadin, heparin, or Lovenox within 14 days before treatment, with the exception of low dose anti-coagulants to maintain intravenous catheter patency.
- Initiation of hormonal agent (such as tamoxifen, anastrazole, or letrozole) in the 30 days before treatment. 6. Patients who have been on a hormonal agent for at least 30 days prior to treatment with progressive or stable disease are permitted to enroll, but required to stay on this hormonal agent for the duration of the study.
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 | Biological | hTERT/Survivin Multi-Peptide Vaccination |
Primary outcome
Number of Adverse Events
Time frame: 1st dose of basiliximab to 30 days after the last vaccination
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 25 Jun 2019.
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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
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing hTERT in people with Metastatic Breast Cancer, run by Abramson Cancer Center at Penn Medicine 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 12 inclusion and 11 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 25 Jun 2019. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Number of Adverse Events (time frame: 1st dose of basiliximab 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 25 Jun 2019.