Breast CancerPhase 1NCT00304096
Vaccine Therapy in Treating Patients With Stage III or Stage IV Breast Cancer
A Phase 1 study testing synthetic breast cancer peptides-tetanus toxoid-Montanide ISA-51 vaccine in people with Breast Cancer, run by University of Virginia at 1 site in United States.
Trial summary
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- synthetic breast cancer peptides-tetanus toxoid-Montanide ISA-51 vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Apr 2008
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the breast
- Stage III or IV disease
- Primary or recurrent disease
- Invasive lobular carcinoma allowed
- HLA-A1, -A2, -A3, or -A31 positive
- Underwent and recovered from prior primary therapy
- Patients with no clinical or radiological evidence of disease who had a previous diagnosis of stage III or IV breast cancer must have undergone prior antineoplastic therapy including, but not limited to, surgery, chemotherapy, and radiotherapy within the past 36 months
- Must have at least one undissected axillary and/or inguinal lymph node basin
- No history of brain metastases
- Hormone receptor status
- Estrogen receptor-positive or -negative tumor
PATIENT CHARACTERISTICS:
- ECOG performance status of 0 or 1
- Body weight > 110 lbs (without clothes)
- Male or female
- Menopausal status not specified
- Absolute neutrophil count > 1000/mm^3
- Platelet count > 100,000/mm^3
- Hemoglobin > 9 g/dL
- Hemoglobin A1c < 7%
- AST and ALT ≤ 2.5 x upper limit of normal (ULN)
- Bilirubin ≤ 2.5 x ULN
- Alkaline phosphatase ≤ 2.5 x ULN
- Creatinine ≤ 1.5 x ULN
- HIV negative
- Hepatitis C negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known or suspected allergies to any component of the vaccine
- No active infection requiring antibiotics
- No New York Heart Association class III or IV heart disease
- No autoimmune disorders requiring cytotoxic or immunosuppressive therapy or autoimmune disorders with visceral involvement, except the following:
- Laboratory evidence of autoimmune disease (e.g., positive ANA titer) without symptoms
- Clinical evidence of vitiligo
- Other forms of depigmenting illness
- Mild arthritis requiring nonsteroidal antiinflammatory drugs
- No medical contraindication or potential problem that would preclude study participation
PRIOR CONCURRENT THERAPY:
- More than 4 weeks since prior surgery
- More than 4 weeks since prior and no concurrent chemotherapy and radiotherapy
- More than 4 weeks since prior and no concurrent allergy desensitization injections
- More than 4 weeks since prior parenteral, oral, or inhaled corticosteroids
- No concurrent inhaled steroids (e.g., Advair® or triamcinolone acetonide)
- Prior or concurrent topical corticosteroids allowed
- More than 4 weeks since prior and no concurrent growth factors (e.g., epoetin alfa, darbepoetin alfa, or pegfilgrastim)
- More than 4 weeks since prior and no concurrent other investigational medication
- More than 4 weeks since prior and no concurrent other agents with putative immunomodulating activity except for non-steroidal anti-inflammatory agents
- Prior and concurrent hormonal therapy (e.g., tamoxifen, raloxifene, toremifene, fulvestrant, letrozole, anastrozole, or exemestane) allowed
- No prior vaccination with any synthetic peptides in this protocol
- Vaccines for infectious disease (e.g., influenza) allowed, provided they are administered ≥ 2 weeks prior to or ≥ 2 weeks after study vaccine
- Short term therapy for acute conditions not related to breast cancer allowed
- No concurrent illegal drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
About this study
Official title: Evaluation of the Safety and Immunogenicity of Vaccination With Multiple Synthetic Peptides in Participants With Advanced Breast Cancer
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating patients with stage III or stage IV breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the safety of a vaccine comprising multiple synthetic breast cancer-associated peptides and a tetanus toxoid helper peptide emulsified in Montanide ISA-51 in patients with stage III or IV adenocarcinoma of the breast.
- Determine, preliminarily, the frequency of immune responses against the 9 class I MHC-restricted peptides in patients treated with the vaccine.
- Determine, preliminarily, the cytotoxic responses of T-cells to allogeneic breast cancer cells and autologous breast cancer cells (when available).
OUTLINE: This is an open-label study.
Patients receive peptide vaccine comprising 9 synthetic breast cancer peptides and tetanus toxoid helper peptide emulsified in Montanide ISA-51 subcutaneously and intradermally once daily on days 1, 8, 15, 36, 57, and 78 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- synthetic breast cancer peptides-tetanus toxoid-Montanide ISA-51 vaccine
- Keywords
- recurrent breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, male breast cancer, invasive lobular breast carcinoma
- Medical subject headings
- Breast Neoplasms, Breast Neoplasms, Male, Carcinoma, Lobular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
synthetic breast cancer peptides-tetanus toxoid-Montanide ISA-51 vaccineBiological
| Study group | Role | What they receive |
|---|---|---|
| Stratum 1: Receiving Hormone Therapy | Experimental | Patients treated with 9 peptide vaccine who received hormone therapy Receives: Biological: synthetic breast cancer peptides-tetanus toxoid-Montanide ISA-51 vaccine |
| Stratum 2: Not receiving hormone therapy | Experimental | Patients receiving 9 peptide vaccine who did not receive hormone therapy Receives: Biological: synthetic breast cancer peptides-tetanus toxoid-Montanide ISA-51 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants Who Experienced Dose-limiting Adverse Events
Safety of the 9-peptide mixture if fewer than 33% of patients experience a dose-limiting toxicity
Measured: 30 days post administration of last vaccine
Secondary outcomes (1)
The Number of Participants With T-cell Responses Against the Vaccine as Measured by Elispot Assay After 14 Day in Vitro Sensitization
Measured: Days 1-78
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2006 (estimated)
- Study startDec 2005
- Primary completionJun 2007
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- David R. Brenin, MD, FACS, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00304096
- Sponsor's protocol ID
- 11992
- Other IDs
- UVACC-BREAST-34, UVACC-HIT-032.7, UVACC-PRC-366-05, UVACC-GCRC-DRB001
- Status last verified
- Feb 2013
- First submitted
- 15 Mar 2006
- Last updated
- 9 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Immunogenicity of Vaccination With Multiple Synthetic Peptides in Participants With Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT00304096
- Acronym / sponsor ID
- 11992
- Conditions
- Breast Cancer
- Keywords
- recurrent breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, male breast cancer, invasive lobular breast carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 17 Mar 2006 (estimated)
- Results
- Posted 9 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating patients with stage III or stage IV breast cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the safety of a vaccine comprising multiple synthetic breast cancer-associated peptides and a tetanus toxoid helper peptide emulsified in Montanide ISA-51 in patients with stage III or IV adenocarcinoma of the breast.
- Determine, preliminarily, the frequency of immune responses against the 9 class I MHC-restricted peptides in patients treated with the vaccine.
- Determine, preliminarily, the cytotoxic responses of T-cells to allogeneic breast cancer cells and autologous breast cancer cells (when available).
OUTLINE: This is an open-label study.
Patients receive peptide vaccine comprising 9 synthetic breast cancer peptides and tetanus toxoid helper peptide emulsified in Montanide ISA-51 subcutaneously and intradermally once daily on days 1, 8, 15, 36, 57, and 78 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stratum 1: Receiving Hormone Therapy | Experimental | Biological: synthetic breast cancer peptides-tetanus toxoid-Montanide ISA-51 vaccinePatients treated with 9 peptide vaccine who received hormone therapy |
| Stratum 2: Not receiving hormone therapy | Experimental | Biological: synthetic breast cancer peptides-tetanus toxoid-Montanide ISA-51 vaccinePatients receiving 9 peptide vaccine who did not receive hormone therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| synthetic breast cancer peptides-tetanus toxoid-Montanide ISA-51 vaccine | Biological | Stratum 1: Receiving Hormone Therapy, Stratum 2: Not receiving hormone therapy |
Primary outcome
The Number of Participants Who Experienced Dose-limiting Adverse Events
Time frame: 30 days post administration of last vaccine
Safety of the 9-peptide mixture if fewer than 33% of patients experience a dose-limiting toxicity
1 secondary outcome
The Number of Participants With T-cell Responses Against the Vaccine as Measured by Elispot Assay After 14 Day in Vitro Sensitization
Time frame: Days 1-78
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
David R. Brenin, MD, FACS principal investigator
University of Virginia
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 synthetic breast cancer peptides-tetanus toxoid-Montanide ISA-51 vaccine in people with Breast Cancer, run by University of Virginia 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?
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 9 Apr 2013. 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?
Yes. Results are posted in the registry (first posted 9 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Number of Participants Who Experienced Dose-limiting Adverse Events (time frame: 30 days post administration of last vaccine). 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 9 Apr 2013.