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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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 groups in NCT00304096
Study groupRoleWhat they receive
Stratum 1: Receiving Hormone TherapyExperimentalPatients 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 therapyExperimentalPatients 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.

  1. 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)
  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.

  1. First posted17 Mar 2006 (estimated)
  2. Study startDec 2005
  3. Primary completionJun 2007
  4. Study completionApr 2008

Resources

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)
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
Data monitoring committee
Yes

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.

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