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Evaluation of the Safety and Immunogenicity of Vaccination With Multiple Synthetic Peptides in Participants With Advanced Breast Cancer

Phase 1
18 Years
Not Enrolling
Breast Cancer

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Trial Information

Evaluation of the Safety and Immunogenicity of Vaccination With Multiple Synthetic Peptides in Participants With Advanced Breast Cancer



- 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

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.

Inclusion Criteria


- 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


- 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

- 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


- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The Number of Participants Who Experienced Dose-limiting Adverse Events

Outcome Description:

Safety of the 9-peptide mixture if fewer than 33% of patients experience a dose-limiting toxicity

Outcome Time Frame:

30 days post administration of last vaccine

Safety Issue:


Principal Investigator

David R. Brenin, MD, FACS

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Virginia


United States: Food and Drug Administration

Study ID:




Start Date:

December 2005

Completion Date:

April 2008

Related Keywords:

  • Breast Cancer
  • 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
  • Breast Neoplasms



University of Virginia Cancer CenterCharlottesville, Virginia  22908